medtronic launches hugo to rival intuitive’s robotic surgery … · 2019. 10. 2. · for the...

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October 7, 2019 Issue 164

R&D

News from the Transcatheter Cardiovascular Therapeutics meeting, pp. 21-23

EDITORS’ PICKS

Quality System Regulation/ISO 13485 harmonization update, p. 5

COMMERCIAL

Abbott wins US FDA approval for its spinal cord stimulator, p. 18

Medtronic Launches Hugo To Rival Intuitive’s Robotic Surgery SystemREED MILLER [email protected]

M edtronic PLC announced plans for its Hugo RAS robotic mini-mally invasive surgery system,

which will compete with Intuitive Surgi-cal Inc.’s da Vinci robotic surgery system.

At its Robotic-Assisted Surgery Investor Update in Hartford, CT, on 24 September, the company announced plans to launch Hugo RAS outside of Europe and the US in the next few months. The company did not disclose where it will initially launch Hugo RAS, but several analysts who were at the meeting in Hartford have suggest-ed the first cases with Hugo RAS will be in India, where Intuitive Surgical does not have a major presence.

At the event, Bob White, president of Medtronic’s minimally invasive therapies group, said the company hopes to earn a CE mark for the system in late 2020 or early 2021, and expects the US Food and Drug Administration to clear Hugo RAS around September 2021.

“This will be a meaningful contributor to us,” White said. “We absolutely believe in the value of the platform.” The compa-ny expects Hugo RAS to contribute less than 50 basis points, or less than 0.5%, to the minimally invasive surgery group’s revenues in fiscal 2021, growing to 250 basis points by fiscal 2023.

Medtronic markets the Mazor robotic system for spine surgery, but Hugo RAS

represents Medtronic’s first effort to com-pete directly with Intuitive Surgical’s da Vinci robotic surgery system for market share in general, urology, gynecology, thoracic, colorectal and bariatric robotic-assisted surgical procedures. (Also see “Brain Therapies Leads Medtronic’s Growth In First Quarter Of Fiscal 2020” - Medtech In-sight, 21 Aug, 2019.)

Traditional minimally invasive surgery accounts for about 30%-35% of all surger-ies and represents a $9bn market. And the market for robotic minimally invasive surgery systems is growing close to 20% annually and is worth about $4bn, ac-

cording to Medtronic. Only about 10% of surgeries in the US and fewer than 2% of surgeries worldwide are performed with robotic assistance, according to the com-pany. About 39,000 surgeons have been trained to use robotic surgical tools and more than 5,000 robotic surgery systems have been installed worldwide. But each of those systems is used, on average, just once a day.

White said the biggest barrier to con-vincing more hospitals to buy robotic sur-gery equipment is not the total upfront price of the equipment, but the high

CONTINUED ON PAGE 8

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explore more:exclusive online contentMarket intel on bioprintinghttp://bit.ly/2pmc8ln

The race continues to heat up in the bioprinting space over which players will first reach the finish line in gaining approval for tissue and organ replacements.

Lobbying dollars http://bit.ly/2nCLmVr

Industry trade groups spend millions of dollars and walk thousands of steps in the halls of the US Congress each year to persuade legislators and their staff to support votes on device-tax repeal. Using lobbying reports downloaded by a public interest group, Medtech Insight has analyzed what industry spent and paid out to hire legislative experts to lobby Congress in the first half of 2019.

MitraClip cost-effectivenesshttp://bit.ly/2pnjDIV

A new analysis of COAPT showed MitraClip is cost-effective compared to medical therapy, and the three-year outcomes from the trial support MitraClip’s durability.

IVDs post-Brexit?http://bit.ly/2ozr7I1

With the current Brexit date less than a month away, the IVD industry is busy providing support to UK manufacturers and the pathology sector in an attempt to ensure no one is left out.

Device Weekhttp://bit.ly/2K5QHg6

In this week’s Medtech Insight podcast, deputy editor Reed Miller reviews the major interventional device trials presented at the Transcatheter Cardiovascular Therapeutics conference in San Francisco, CA.

medtech.pharmaintelligence.informa.com

inside: Cover / Medtronic Launches Hugo To Rival Intuitive’s Robotic

Surgery System – The company unveiled its new modular robotic surgery system for minimally invasive surgery at a special event in Hartford, CT.

EDITORS’ PICKS 5 QSR/ISO 13485 Harmonization Update – All signs point

to the US agency exercising enforcement discretion for device-makers when it rolls out a new final rule that merges the Quality System Regulation with international standard ISO 13485.

6 BD Names COO Thomas Polen As Next CEO; Vince Forlenza Will Retire In January – Polen led BD’s $24bn acquisition of Bard in 2017 and the $12bn acquisition of CareFusion in 2015. Forlenza has been with BD for almost 40 years, including eight as CEO.

7 Where Ireland Stands With No-Deal Brexit As It Acts To Protect Potentially Vulnerable Devices – In just a few weeks’ time, there is the risk that the UK, including Northern Ireland, could depart the EU. But where does the Republic of Ireland stand and what is it advising in these uncertain times?

POLICY & REGULATION 10 Industry Optimistic About Second CDS Draft Guidance;

FDA Releases More Final Software Guidances – After strong pushback to a clinical decision support (CDS) software draft guidance, it seems the US agency has decided to heed industry concerns to take a more risk-based approach by issuing another draft of the guidance.

13 New Guidance From FDA Lays Bare Types Of Submissions That Must Be Filed Electronically – A short, seven-page draft guidance from the US agency lists submissions that must be sent to the FDA in an electronic format.

13 FDA Raises Questions On Metal Implant Safety – The US agency is prioritizing research into ways metals in implanted devices may impact human health via two new papers and a planned November panel meeting.

21 10 18

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4 | Medtech Insight | October 7, 2019 © Informa UK Ltd 2019

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REED MILLER @[email protected]

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14 Draft Guidance Doc From FDA Details Lab Accreditation Pilot – The US FDA detailed its proposed approach to the Accreditation Scheme for Conformity Assessment (ASCA) in a new draft guidance document.

15 MedTech Europe’s Bisazza: How Expert Panel Delays Have Caused Uncertainty For Companies – Medtech manufacturers are substantially ready to demonstrate compliance with the EU MDR for new high-risk devices, but the system for checking notified body reviews of their clinical work is causing hold-ups for some highly innovative products, MedTech Europe’s Oliver Bisazza says.

COMMERCIAL 17 LifePod Debuts ‘Proactive’ Voice Assistant Designed To

Ease Elder Care – In October, health IT startup LifePod will debut its proactive voice-assistant device for caregivers to help improve care of the elderly.

18 Abbott Wins FDA Approval For ‘Low Dose’ Non-Rechargeable Spinal Cord Stimulator – Abbott won US FDA approval for its Proclaim XR spinal cord stimulator.

R&D 20 Feasibility Trial Of Medtronic’s Intrepid Transfemoral

TMVR Begins – A new trial will evaluate the feasibility of implanting Medtronic’s Intrepid transcatheter mitral valve replacement system through a transfemoral approach after the Intrepid TMVR study showed the feasibility of implanting Intrepid through the transapical approach.

21 TCT 2019: Boston Scientific’s Acurate Neo TAVR Misses Endpoint In SCOPE I – Boston Scientific is looking ahead to the next-generation Acurate neo2 valve after results of SCOPE I showed worse rates of kidney injury and severe aortic regurgitation in patients treated with the self-expanding Acurate neo valve than in patients treated with Edwards’ Sapien 3 valve.

23 TCT 2019: IDEAL LM Inconclusive, While Onyx ONE Boosts Polymer-Based DES – Data from two late-breaking drug-eluting stent trials, presented on 26 September at Transcatheter Cardiovascular Therapeutics meeting in San Francisco, prompted mixed reactions from interventional cardiologists.


� E D I T O R S ’ P I C K S �

QSR/ISO 13485 HARMONIZATION UPDATE

FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s EndSHAWN M. SCHMITT [email protected]

T he US Food and Drug Administration will likely exercise enforcement discretion for device-makers when the agency rolls out its new rule that harmonizes the Qual-

ity System Regulation with international standard ISO 13485.“We’ll give companies time on the transition. So even when

it goes final, there will be a period of time to make that transi-tion,” said Jeff Shuren, director of the agency’s Center for De-vices and Radiological Health (CDRH).

The FDA’s QSR has been the bedrock rule for manufactur-ing safe and effective medical devices to be sold in the US for more than two decades. Meanwhile, ISO 13485:2016 is used by device firms to ensure quality systems compliance with regulators in a variety of countries, including Canada, Japan, Australia and the 28 member states of the EU.

“We’re looking to make this [transition to a new US rule] least burdensome as possible,” Shuren said on 25 September at the MedTech Conference in Boston, MA. “Currently, if you are making product for multiple jurisdictions, you may already have to comply with [ISO 13485] for a bunch of countries, and then you have to do the QSR for us. [But soon] it essentially will be ISO.”

That’s because, he said, “essentially the standard will, for the most part, replace the QSR. You might see some add-ons that are in there when we build [the rule] out. But 13485, the 2016 version, matches up with what we do about 95%.”

Such “add-ons” may include a provision for Medical Device Reporting (found under QSR Sec. 820.198) and requirements around so-called “critical devices,” which can be found in the QSR under Sec. 820.65, “Traceability,” just to name two. (Also see “The QSR/ISO 13485 Maze: How FDA’s Satellite Device Rules Will Complicate A Quality System Regulation Rewrite” - Medtech Insight, 20 Aug, 2018.)

The FDA announced in May 2018 that it would update the QSR. The agency’s official regulatory agenda says it will re-lease a draft of the merged QSR/ISO 13485 rule this month. However, an industry insider close to the situation and famil-iar with the FDA’s thinking told Medtech Insight on 26 Septem-ber that the draft likely won’t be out until the end of the year because of “disagreements technically on the inside” of the agency.

“The draft proposal is still in quite a flux,” the insider said.When a blended final rule eventually does go “into effect,

we will flip the switch at that date [and toss out the QSR because] we cannot operate under two separate systems,” Shuren said. “It’s just too challenging for our inspectors. But

we will give a lead time for everyone to get up to speed and make changes.”

By exercising enforcement discretion, the agency would give manufacturers and field investigators alike time to be-come accustomed to the new regulation’s requirements.

“To implement [the rule], we’re going to have to change what we do in an inspection, and that’s going to involve a lot of work on our part,” Shuren said. He noted that investigators will have to be trained and inspection-related documents will have to be modified.

“And, of course, that will cause ripple effects through a bunch of our documents we currently cite. So we’re going to have to go in and make changes to those, as well,” he said.

Published online 26 September 2019

FDA device center director Jeff Shuren talks about the QSR/ISO 13485 mash-up at the MedTech Conference on 25 September

“To implement [the new regulation], we’re going to have to change what

we do in an inspection.” – Jeff Shuren

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BD Names COO Thomas Polen As Next CEO; Vince Forlenza Will Retire In JanuaryREED MILLER [email protected]

T homas Polen will take over as the CEO of Becton Dickin-son & Co. (BD) CEO on 28 January 2020 when current CEO Vincent Forlenza retires, the company announced on 26

September. Forlenza will stay with the company as the board of directors’ executive chairman.

For the last year, Polen has been BD’s COO, overseeing BD’s three business segments – medical, interventional and life sciences – while leading global research and development, innovation, opera-tions and the commercial organization for the Americas region.

Polen led BD’s $24bn acquisition of C. R. Bard Inc. in 2017, which brought BD into fast-growing interventional device markets. (Also see “BD, CR Bard Merger To Create Vascular Access Device Giant” - Medtech Insight, 24 Apr, 2017.) As part of that deal, BD off-loaded its slow-growing respiratory solutions business. (Also see “Earnings Winners & Losers: Medtech ‘Pure-Plays’ BSX, ISRG, BDX, VAR, RMD” - Medtech Insight, 8 Aug, 2017.)

He previously served as president for BD’s medical segment, which markets diabetes, medication management and drug- delivery products. He led the $12bn acquisition of medication-management company CareFusion in 2015 and has led BD’s ex-pansion into informatics and digital health. (Also see “Becton Dick-inson Adds A Bigger Jewel To Its String Of Pearls” - In Vivo, 8 Sep, 2015.)

Polen first joined BD in 1999 and served in various sales and marketing roles before leaving in 2004 to work at Baxter, where he led that company’s injectable pharmaceuticals business. He came back to BD in 2009 as president of the preanalytical systems busi-ness and then served in a series of leadership roles before being named president of BD in April 2017 and COO in October 2018.

“Tom is a strategic, customer-centric executive who brings tremendous energy, a deep understanding of the industry and health-care technology, and a strong track record of delivering results,” Forlenza said.

At the company’s presentation at the Wells Fargo Health Care

Conference on 4 September, Polen said the integration of Bard and CareFusion have both been extremely successful, so fiscal 2020, which begins on 1 October, will be “a year in which we’re pivoting to the next phase of value creation for the company.”

“As we think about the next phase of value creation, we reallyare going to be pivoting to focus on running the company

right. Top of mind is not another large integration, another [or] a large M&A deal,” he said. However, Polen suggested the company will consider smaller acquisitions in the future. As it has integrated CareFusion and Bard over the past six years, the company has been gradually paying down its debt and will be able to “free up” $2bn over the next year. With that money, BD will “start looking at acceler-ating tuck-in M&A,” he said.

“As we move into 2020 and as we think about that next phase af-ter that, we’re now really going to be focusing on capitalizing on the new markets that we’ve just entered into,” he said. BD recorded rev-enue of $15.9bn in 2018. In August, BD projected revenue for all of fis-cal 2019 would be up 5% to 6% on a constant-currency, comparable basis, with earnings per share up 12% to between $11.65 and $11.75.

Polen said he is committed to improving upon those results with cost containment and cost synergies within the company. “There are still opportunities for there to be fewer plans, more efficient processes, et cetera,” he said. “We’re quite positive on our ability to drive continued savings there and to help us fuel that double-digit EPS growth going forward.”

FORLENZA’S RETIREMENT IS NOT A SURPRISE Forlenza was asked whether he planned to retire soon at the Morgan Stanley Global Health Care Conference on 11 Septem-ber. While not offering specifics, he said “from the first day that I became CEO, I started working with the board on succession [and] that doesn’t just mean the CEO role.”

In a September 26 note, Wells Fargo analyst Larry Biegelsen wrote: “The timing of the transition makes sense as BD enters the last year of the Bard integration and is looking at the next phase of growth in FY 2021 and beyond. Overall, we do not expect any ma-terial changes to BD’s outlook or strategic direction under Tom’s leadership.”

Forlenza has been with BD for almost 40 years, including in roles in the company’s diagnostics and biosciences units, lead-ing R&D and corporate strategy. He became CEO in October 2011 and chairman in July 2012.

He served as chairman of AdvMed from 2015 to 2017 and cur-rently serves on the trade organization’s Legal Committee. He is also on the boards for Moody’s and Valley Health Systems.


“As we think about the next phase of value creation, we really are going to be pivoting to focus on running the company right. Top of mind is not another large integration, another [or] a large M&A deal.” – Tom Polen



Where Ireland Stands With No-Deal Brexit As It Acts To Protect Potentially Vulnerable Devices AMANDA MAXWELL [email protected]

Ireland’s Health Products Regulatory Au-thority (the HPRA) is conducting a review of how medtech products will be im-

pacted by a no-deal Brexit so it can focus contingency planning efforts on poten-tially vulnerable medical devices.

It says it wants to ensure that appropri-ate actions have been taken by suppliers of medical devices and diagnostics to minimize and address any risks to conti-nuity of supply.

The HPRA only has jurisdiction in the Republic of Ireland, and not in Northern Ireland, which is part of the UK. If the UK leaves the EU on 31 October, as Prime Minister Boris Johnson still plans, then Northern Ireland will no longer be part of the EU.

If the EU and UK can agree a withdrawal agreement, then the likelihood is that medtech regulations and trade would continue as at present for a couple of years while the long-term future arrange-ments are hammered out. But if there is no deal, then there will be far-reaching consequences, especially in the UK and Ireland, including in their regulatory posi-

tion, which would mean fundamental dif-ferences between Northern Ireland and the Republic of Ireland in medtech trade.

A draft withdrawal agreement had been negotiated by former Prime Minis-ter Theresa May, which includes an Irish “backstop.” Under the backstop, the UK would enter into a single customs terri-tory with the EU if the UK and EU failed to agree future trade arrangements at the end of the withdrawal agreement transi-tion period.

But it is looking increasingly unlikely that the UK and EU will agree to the terms of this withdrawal deal and that the UK is heading for a no-deal Brexit where it would leave the EU without any agree-ment in place. Johnson has declared the backstop arrangement “dead.”

Ireland’s only medtech notified body, NSAI, is based in the Irish capital Dublin, and so will not have to cease CE-marking activities in the event of a no-deal Brexit. NSAI is notified under all three current EU medical device directives and, Medtech Insight understands, is seeking designa-tion under both the EU’s Medical Device

Regulation and IVD Regulation. In a recent statement, the HPRA says:

“It is absolutely critical that if you become aware of a Brexit-related issue that could potentially affect the supply of medical devices in Ireland that you inform the HPRA immediately by emailing [email protected] and we will liaise with the Health Service Executive (HSE) and Department of Health on these issues.”

Given HPRA’s view that “there is a sig-nificant risk of a ‘no deal’ Brexit on 31 Oc-tober 2019,” the agency asks companies to ensure enough stock levels and conti-nuity of supply before 31 October as well as post-Brexit. This, it says, includes con-sideration of stocks in the supply chain and ensuring arrangements to allow for “timely replenishment of such stocks in-cluding custom requirements where ap-plicable and allowing for potential delays during transportation.”

Together with colleagues from the HSE, the HPRA says, it continues to con-tact medical device and IVD manufac-turers, authorized representatives and distributors to determine how both regu-latory and supply matters relate to their product(s) marketed in Ireland, to request assurances in respect of their contingen-cy planning, and to identify any potential issues regarding the availability of specif-ic products associated with Brexit.

In the notice, the HPRA highlights the need for medical device companies to transfer CE-marking certificates from no-tified bodies based in the UK to groups located in one of the 27 member states that will still be in the EU after Brexit. It also states that medical device compa-nies need to ensure they have an EU 27 authorized representative so that they can continue to market their CE-marked devices on the EU market.

The HPRA says it remains available to discuss challenges that stakeholders face and to clarify any aspects as required.




cost per procedure. Medtronic believes designing Hugo RAS to be flexible and mobile will make it easier for hospitals to use it more often, keeping the per-procedure costs down. This will improve the value to the hospital and third-party payers while allowing more patients to safely undergo minimally invasive pro-cedures instead of open surgery.

Hugo RAS includes a universal tower, a surgeon control console, and up to four independent carts that carry the robotic arms that control the surgical tools.

Hugo RAS’s universal tower contains 2D and 3D visualization technology cre-ated by Storz and Medtronic’s FT10 gen-erator that powers the system’s surgical tools. Megan Rosengarten, the general manager of the surgical robotics busi-ness within Medtronic’s minimally in-vasive surgery group, explained that the Storz visualization components, the generator and all the software needed to run them are designed to be “up-

gradeable” as technology improves. Hospital administrators have repeatedly

told Medtronic that they are afraid of in-vesting millions of dollars in a technology that could be obsolete in a year.

“We took that in, and said, ‘How are we going to build a system that we can then

commit to being able to upgrade in the field or the hospital when technology ad-vances, so that you’re not required to re-place your entire system?,’” she said. “[This approach is] increasing the return on in-vestment in robotics for our customers.”

The control console has an “open de-

“ The modular design is in our view one of the more compelling attributes of Hugo.” – Pito Chickering

Medtronic Hugo RAS System components

CONTINUED FROM PAGE 1

CHECKLISTIn its Brexit preparedness checklist, the HPRA lists the following tasks that medtech and pharma companies need to consider with respect to the supply chain and customs, and specific regulatory con-siderations for medtech companies, in-cluding IVD companies.

Supply Chain: Regarding the supply of medicines, medical devices and IVDs, companies are requested to:

• Map your supply chain to determine Brexit exposure, including route to market;

• Assess how Brexit may impact your ability to supply the Irish market;

• Take the necessary steps to ensure enough stock levels and continuity of supply both in the period leading up to 31 October and after Brexit; and

• Review stocks at wholesale level and ensure arrangements are in place to allow for timely replenishment of such stocks, including custom

requirements where applicable and allowing for potential delays during transportation.

Customs: Here companies are requested to:

• Register with Revenue for an EORI number (European Union registration and identification number for busi-nesses which undertake the import or export of goods into or out of the EU);

• Understand what is needed to fulfill customs declaration requirements;

• Consider a customs agent/broker or in-house management to complete declarations;

• Consider what authorizations or simplifications about customs proce-dures might be relevant;

• Determine whether you must com-ply with UK customs requirements;

• Identify classification codes for de-vices/products/ingredients; and

• For suppliers sourcing devices from the UK, prepare for the additional

responsibilities you will have as an importer when sourcing products from the UK post-Brexit.

Medical Device Regulatory Compliance: Ensure all activities are being undertaken to meet EU regulatory requirements by 31 October. This includes the following:

• For devices certified by UK notified bodies – confirm with the manu-facturer that they will transfer to an EU-27 notified body by 31 October and that there is a plan for continued certification of the devices;

• For devices manufactured in the UK or where UK authorized representa-tives are used – ensure the authorized representative has been designated in an EU-27 member state; and

• For clinical investigations, transfer of any UK-based sponsor or legal repre-sentative to the EU/EEA.


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sign” rather than forcing the operator to be confined in a small space with a “periscope view” that isolates them from the patient and the rest of the staff in the operating room. “What we heard [from surgeons] is, ‘It’s very important for me to not be isolated from my patient and what’s going on there. It’s very impor-tant for me to feel connected to the overall staff and the activities going on and the environment,” she explained. The console was also designed to reduce strain on the operator’s back and neck.

The carts that hold the robotic arms are mobile so they can move between operating rooms or moved out of an op-erating room to quickly make room for surgery that does not require the robotic system, Rosengarten said. This mobility will make it easier for surgical teams to schedule multiple robotic surgeries in a row, because they will be able to prepare one operating room for a surgery while the robotic arms are still being used in a different room, and then move the ro-botic arms to the room that is already prepared and start the next surgery quickly, she explained.

“[Hospitals] can buy the laparoscopic tower and they can move that into every single one of their ORs and they can buy a fleet of robotic arms that can be shared across those operating rooms,” Rosen-garten said.

ANALYSTS EXPECT HUGO TO SUCCEED, BUT WANT MORE INFORMATIONIn a 24 September analyst note, Deutsche Bank’s Pito Chickering wrote, “The modu-lar design is in our view one of the more compelling attributes of Hugo.” Chickering added that Medtronic’s “strong established presence in minimally invasive surgery will be instrumental in Medtronic making in-roads in the robotic surgery space.

“The company’s unwillingness to provide much in the way of specifics here was frus-trating, albeit not surprising given the com-petitive considerations,” Chickering said. He pointed out that some analysts expected Medtronic would sell Hugo RAS at below cost, at least initially, and generate revenue entirely from per-procedure costs. “But

the clear message today was that this will not be the strategy,” Chickering said. “The bottom-line goal will be to enable robotic surgery procedures at cost parity with simple laparoscopy – but how this will be achieved remains a key open question for us coming out of the meeting given the huge capital expenditure involved.”

Hugo RAS will compete with Intuitive Surgical’s da Vinci robotic surgery system, which has an almost 20-year head start in the market with more than 5,000 systems already installed. Chickering also pointed out that Intuitive also has a “huge advan-tage” in informatics and analytics from the data it has collected from the surger-ies performed with the da Vinci so far. But “the global surgery market is massive and minimally invasive surgery/robotics pen-etration remains very low, thus leaving ample room for multiple players,” he said. (Also see “Market Intel: Rivals Catching Up To Intuitive Surgical In Fast-Growing, Fast-Innovating Robotic-Assisted Devices Mar-ket” - Medtech Insight, 10 Nov, 2017.)

On 24 September, Jefferies analyst Raj Denhoy wrote that Medtronic’s projec-tions for Hugo RAS’ revenue contribu-tions amount to about $40m, $115m and

$200m of incremental revenue over the next three years, which would contribute about 0.25% to Medtronic’s overall rev-enue during this early phase of the mar-ket launch. “While some conservatism is clearly baked-in, the initial targets appear modest,” especially relative to the $5bn in revenue Intuitive is forecasting for

2022 (Also see “International Demand For Robotic Surgery Drives Intuitive Surgical’s Revenues Up 21% in Q2” - Medtech Insight, 19 Jul, 2019.) “Despite this modest early look, we still see robotics as having block-buster ($1bn-plus) potential over time as the launch evolves.”

In a 24 September note, Wells Fargo an-alyst Larry Biegelsen said he expects that the specific surgical instruments for Hugo RAS will be more durable than compa-rable instruments for da Vinci, which will help make Hugo RAS cost-effective.

“It is worth noting that approximately 70% of Intuitive Surgical’s revenues are generated from recurring revenues, in-cluding over 50% from instruments and accessories,” Biegelsen wrote. “The com-pany’s response will have to be closely monitored, especially if Medtronic is able to successfully drive instrument usage higher and cost lower.”

He expects the initial adopters of Hugo RAS to be mostly academic centers and community hospitals with the company focusing initially on colorectal surgery and prostatectomy surgeries.


“ The global surgery market is massive and minimally invasive surgery/robotics penetration remains very low, thus leaving ample room for multiple players.” – Pito Chickering

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Industry Optimistic About Second CDS Draft Guidance; FDA Releases More Final Software GuidancesFERDOUS AL-FARUQUE [email protected]

A lmost two years after publishing a controversial draft guidance on clinical decision support (CDS) software, the US Food and Drug Administration is taking another stab

at the issue with an updated draft guidance to the delight of in-dustry stakeholders.

On 26 September, the agency released the Clinical Decision Support Software guidance – a revised version of a document published by the FDA in December 2017 that was met with strong pushback from industry. (Also see “Draft Clinical-Decision-Support Software Guide Paves A Path, But May Need Some Work” - Medtech Insight, 8 Dec, 2017..)

Bakul Patel, associate director for digital health at the FDA’s Cen-ter for Devices and Radiological Health (CDRH), says there was some confusion in the original draft over how the agency would decide to categorize the various software. In a 25 September in-terview with Medtech Insight before the new draft was released, he said stakeholders voiced confusion over the difference between clinical decision software and patient decision software.

Now, however, the agency has decided to do away with those distinctions and instead has broken the software categories into device CDS and non-device CDS products. Further, the guidance takes a risk-based approach that uses a 3x3 matrix laid out by the International Medical Device Regulators Forum (IMDRF) on how to determine what CDS should be regulated.

The 3x3 matrix can be found on page 14 of the IMDRF’s 2014 “Software as a Medical Device: Possible Framework for Risk Cat-egorization and Corresponding Considerations” guidance that intended to help regulators figure out what SaMDs should be regulated depending on their level or risk and their intended use.

“The feedback we got overwhelmingly was, ‘How does it fit into the entire risk framework?’” Patel said. “We got a lot of ques-tions about this distinction between patient decision support and clinical decision support.”

The previous guidance was titled “Clinical and Patient Support Software.” In an effort to avoid confusion, the new guidance was simply titled “Clinical Support Software,” according to Patel. He said he’s not enamored of the term “CDS,” but because it’s more commonly accepted, the agency has stuck with the term.

Patel notes the new draft document tries to fit the require-ments for CDS under the 21st Century Cures Act to align with the IMDRF’s risk-based framework. While he says that was the inten-tion of the original draft guidance, he believes the new version better addresses that issue.

Under the new risk-based framework, the FDA would not regulate CDS products that were transparent in showing how they derived their clinical decision recommendations and how they were being used by a health-care profes-sional. Even in a situation where the software

“ This is progress, albeit maybe smaller steps than it might otherwise appear.” – Bradley Merrill Thompson

The draft document tries to fit the requirements for CDS under the 21st Century Cures Act to align with the IMDRF’s risk-based framework.

LISTENCheck out our recent Device Week podcast for more info

on the FDA’s CDS draft guidance – and more: https://bit.ly/2nVs1OJ

https://bit.ly/2nVs1OJ



wasn’t fully transparent but the risk was low, the agency says it could use its regulatory discretion to refrain from oversight of the product. Similarly, if a CDS product is catered for use directly by patients and is transparent, it may qualify under the FDA’s regula-tory discretion as well if it’s considered to be a low-risk device.

There was concern in the previous draft that machine learning CDS software would need to be designed in a way that the user would have to be able to come to the same conclusion indepen-dently of the software to avoid oversight by the FDA. However, Patel noted that the current version does not emphasize how the decision algorithm is derived. Instead, the concept is that the product needs to be designed in a way that the end user is able to understand how the software came to its clinical decision in layman’s terms.

“It’s not about machine learning or not, it’s more about, can you explain what’s going on and how the software came to that decision,” he said. “It’s not about showing the user the formula.”

Over the past few years, Patel and his team at the FDA have been busy producing a slew of digital health guidance docu-ments outlining FDA’s risk-based approach to mobile health, de-veloping a precertification program, and more recently, issuing a white paper on how the agency is looking at regulating artificial intelligence and machine learning devices.

He says the way to view all of these puzzle pieces is to look at policy guidances – such as the CDS guidance – as part of a separate effort from the pre-cert program and AI work that the FDA is do-ing. The policy guidances are trying to help industry understand what types of products the agency will regulate using a risk-based approach, whereas the other pieces are intended to address how the agency will regulate products if they fall under its jurisdiction.

PROGRESS – BUT NOT FAR ENOUGH?Bradley Merrill Thompson, an attorney with Epstein Becker & Green, has been perhaps the most vocal critic of the original draft guidance. As the spokesperson for the now-defunct CDS Coalition, he has fought for the FDA to adopt the IMDRF’s risk-based approach. While he says the new draft guidance does that better, it still doesn’t go far enough in his view.

“This is progress, albeit maybe smaller steps than it might oth-erwise appear,” Thompson told Medtech Insight. “FDA is re-pro-posing its CDS guidance to address many of the concerns that the CDS coalition expressed nearly two years ago.”

The main concern Thompson raised was to ask the FDA to take a risk-based approach, and now it appears the agency has not only adopted that approach, but also the one specifically asked for by the coalition. Despite the progress, he says the agency only took a “very small step.”

The CDS Coalition had asked the agency to not regulate soft-ware as a medical device (SaMD) that falls into Category 1 of IM-DRF’s framework, which includes three subcategories:

Software that provides information to drive clinical manage-ment of a nonserious disease or condition;Software that pro-vides information that merely informs clinical management of a serious disease or condition; and Software that provides infor-

mation that merely informs clinical management of a nonserious disease or condition.

“As it turns out, FDA is only proposing to use enforcement dis-cretion for the very last of those three subcategories,” Thompson said. “The agency is proposing to regulate the first two subcat-egories even though they fall within Category 1: the lowest risk category more broadly.”

He’s especially disappointed that FDA plans to continue regu-lating software that provides information to drive clinical man-agement of nonserious diseases or conditions, which Thompson says will be detrimental to innovation.

“In terms of impact on innovation and patients, this step is in a positive direction, but not nearly far enough,” Thompson said. “As already observed, there will be numerous companies making software directed at nonserious conditions that will be very dis-appointed that FDA intends to regulate their CDS.

“I meet with entrepreneurs developing CDS on almost a daily basis to answer questions about what is and is not regulated,” he added. “Indeed, with some friends, we traveled the country throughout the spring meeting with literally hundreds of entre-preneurs developing AI for health care at eight major universities to talk about this very issue.”

Thompson said since the FDA began working on digital health regulations in 2012, the agency said it was going to take a risk-based approach to SaMD and other such products. However, he argues that was not manifested in the original CDS guidance and the agency’s explanation was that it would address the risk-based approach through its ongoing work in the pre-cert program.

“They have clearly changed their minds about that, and I think that’s exactly the right thing to do,” he noted.

The pre-cert program is a new pathway the FDA is develop-ing that could allow certain medical software manufacturers to get their products to market with less agency oversight. The pro-gram, currently in pilot phase, will be founded on how much the agency trusts the company based on certain metrics the compa-nies would provide FDA.

Thompson cautioned that the pre-cert program isn’t develop-ing into the panacea that some had hoped and instead it seems companies will likely have to go through other loopholes to qual-ify for the program if and when it materializes.

Overall, Thompson says he appreciates that the FDA has come

“ The agency received feedback from many stakeholders advising us on improvements that could be made to better clarify the agency’s oversight of CDS products.” – Amy Abernethy




to the realization that beyond addressing the need for transpar-ency as directed under the 21st Century Cures Act, the agency is helping define what CDS products will be regulated and is taking a risk-based approach.

When the FDA initially asked for comments on the original CDS guidance, Thompson says the CDS Coalition filed a five-page document with low-risk software that were already on the market and would be regulated under that framework.

After filing their comments on the December 2017 draft guidance, Thompson sat down with FDA officials on behalf of the coalition and the agency flatly told him it would not take a risk-based approach as it is trying to do in the new draft.

As a result, the CDS Coalition shuttered in 2018 believing it would not be able to make any progress on the issue, but Thompson himself has been using the podium at various con-ferences and industry meetings to highlight what he saw were the problems of the original CDS draft guidance.

“I hadn’t gotten any whiff that FDA was thinking about changing that view,” he said. “They had not shared that with me, so this is a total surprise.”

But with the new guidance, Thompson says he’s thinking about reaching out to CDS manufacturers to perhaps revive the coalition and file comments to the FDA on the new guidance.

Another industry source, who didn’t have the opportunity to read the new draft guidance but had been briefed more broadly to the change in approach the FDA was taking, said it is “a great step for everyone” and shows that the agency cares about what the industry thinks.

The source – who spoke to Medtech Insight on background because they weren’t cleared to speak on the record by their organization – also commended the agency for looking to use a global harmonized approach so such devices can easily be developed and marketed across regulatory jurisdictions.

While supportive of the notion of trying to harmonize the FDA’s CDS regulations with those of the IMDRF, the source did say there is concern it may cause confusion in the marketplace, especially if nobody else is following the IMDRF guidance except for the agency. The issue can probably be addressed within the new draft guidance if the FDA is looking to simply leverage the spirit of IMDRF’s thinking rather than trying to be more specific, he said.

“It looks like FDA listened to the commenters [on the original draft] and said, ‘Another draft is more warranted than putting out a final guidance,’” the source said. “I can’t think of many examples where they went to a second draft before going to a final version. …I’m really glad we’ll have a second crack at a review and a comment period.”

Despite not going as far as he had hoped, Thompson too commended FDA for listening to stakeholder concerns about how the CDS guidance could have impacted his industry.

“Overall, today is a good day that will make a difference in the lives of at least some patients,” he said. “I have to take my hat off to FDA for reversing course and approaching this issue so sensibly.”

Stakeholders interested in commenting on the new draft guid-ance can do so on www.regulations.gov under docket no. FDA-2017-D-6569 until 26 December.

WHAT THE FDA WILL AND WILL NOT REGULATEAmy Abernethy, FDA deputy principal director, weighed in on the new draft guidance, saying the agency took industry comments seriously to develop a more risk-based approach to CDS regulation.

“After first publishing the draft guidance in 2017, the agency received feedback from many stakeholders advising us on im-provements that could be made to better clarify the agency’s oversight of CDS products,” Abernethy said in a release. “We heard you and worked to incorporate that important feedback.”

“In this [new] draft guidance, we propose to focus our reg-ulatory oversight on CDS functions that are intended to help health-care professionals and patients inform their clinical management for serious or critical conditions, and that are not intended for health-care professionals to independently evalu-ate the basis of the software’s recommendations,” she said.

Alongside the CDS guidance, the FDA also released a final guidance titled “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.”

As required by the 21st Century Cures Act, the guidance clari-fies the agency’s thinking on what kinds of software are not considered to be medical devices by the agency. When the FDA initially released its risk-based mobile app guidance a few years ago, the agency received praise from stakeholders for trying to oversee certain medical software based on their risk. But stake-holders were concerned that there were too many gray areas where it wasn’t apparent to companies if their product would be treated as a medical device.

To address this, the new guidance lists certain health apps, such as mobile apps used for wellness, as being outside the FDA’s regulatory oversight.

“The digital health technologies described in this guid-ance … have been previously discussed in existing medical software guidances,” Abernethy said. “That’s why today [26 September] we are also updating four previously issued FDA final guidances to align with interpretations and policies un-der the Cures Act: Final Guidance on Policy for Device Soft-ware Functions and Mobile Medical Applications; Final Guid-ance on General Wellness: Policy for Low Risk Devices; Final Guidance on Off-The-Shelf Software Use in Medical Devices; Final Guidance on Medical Device Data Systems, Medical Im-age Storage Devices, and Medical Image Communications Devices.”

She went on: “Changes to these documents include clarifi-cation that many products previously under enforcement dis-cretion no longer are medical devices under the 21st Century Cures Act, and therefore are not subject to FDA’s regulations and oversight.”




FDA Raises Questions On Metal Implant SafetyELIZABETH ORR [email protected]

R esearch by the US Food and Drug Administration backs concerns that human immune systems may react to certain metals in im-planted devices, the agency said in a 30 September announcement.

Patients, caregivers and advocacy groups have long reported that some patients experience localized or systemic physical reactions includ-ing pain, fatigue, rashes and generalized weakness after receiving metal implants. Devices such as metal-on-metal hips and the Essure birth con-trol device have been removed from the market due to similar concerns. And a growing body of evidence supports those claims, the FDA says.

“Based on our evaluation, we believe the current evidence, although limited, suggests some individuals may be predisposed to develop a local or systemic immune or inflammatory reaction when exposed to certain metals contained in select implantable devices,” an agency website reads.

In response, the FDA wants to work with stakeholders to identify gaps in the science around how patients respond to implant materials and consider new approaches to the issue. As initial steps, the 30 Sep-tember announcement included research papers on metal implants and dental amalgams. The agency also scheduled an immunology de-vices panel meeting for November.

“We are continuing our efforts to determine how to better identify patients who might be at increased risk of experiencing a hypersensi-tivity response before they receive a metal-containing implant, so that they, along with their health-care providers can better consider those risks along with the device’s benefit,” FDA device center director Jeff Shuren said in a statement.

The reports, “Biological Responses to Metal Implants” and “Epidemo-logical Evidence on the Adverse Health Effects Reported in Relation to Mercury from Dental Amalgam,” represent an in-depth look at current device materials science. The dental amalgam paper found that evi-dence doesn’t support a link between the use of dental amalgam con-taining mercury and adverse health events, but noted that important research gaps still existed. Meanwhile, the paper on metal implants summarizes current scientific knowledge on metal implants, including how the body effects device structure, and function and how the metal components wear over time and interact with the body’s immune cells.

The Immunology Devices Panel meeting is scheduled for 13-14 November in Gaithersburg, MD. It will focus on assessing the poten-tial for immune and inflammatory reactions in patients who receive device implants that include certain metals or metal alloys, as well as whether current biocompatibility standards are sufficient. In addi-

New Guidance From FDA Lays Bare Types Of Submissions That Must Be Filed ElectronicallySHAWN M. SCHMITT [email protected]

T he US Food and Drug Administration released an easy-to-digest draft guidance on 25 September that lists the types of submissions that must be

sent to the agency in an electronic format.The FDA’s short, seven-page “Providing Regulatory

Submissions for Medical Devices in Electronic Format,” dated 26 September, says these submission types must be electronic:

• 510(k)s• De novos• PMAs• Modular PMAs• Product Development Protocols (PDPs)• Investigational Device Exemptions (IDEs)• Humanitarian Device Exemptions (HDEs)• Emergency Use Authorizations (EUAs)• Q-submissions• Subsequent submissions (including amendments,

supplements and reports)The draft document notes that Investigational New Drug

(IND) applications and Biologics License Applications (BLAs) should be submitted electronically, too.

“Whether it is a single-page submission (eg, a change in correspondent) or a multi-volume submission, the submis-sions in electronic format requirements apply,” the draft states.

It goes on to say that a non-electronic submission won’t be filed or received by the agency unless it has been exempted or waived from e-submitting.

The document makes clear that compassionate use re-quests and adverse event reports do not have to be submit-ted electronically – although the FDA strongly recommends that such submissions are sent to the agency that way.

The agency says additional draft guidances are on the way that will “specify the electronic formats, subject matter and scope of applicability for submissions,” and notes that the forthcoming documents will lay out a timetable for imple-menting e-submissions.

Comments on the draft guidance are due at Regula-tions.gov by 25 November.


The FDA has scheduled an immunology device panel meeting for November.




tion, the FDA will take panel advice on what additional scientific information may be needed as part of the premarket review and postmarket surveillance of metal-containing devices and dental amalgams. The panel will also evaluate potential gaps in cur-rent scientific knowledge to see what types of additional studies might help mitigate current risks.

A public docket for the meeting is open until 13 December. The FDA will give panelists access to comments submitted by 10 October, while materials received later will be reviewed only by the agency.


Draft Guidance Doc From FDA Details Lab Accreditation PilotELIZABETH ORR [email protected]

M edical device manufacturers may have more options for certifying that their products meet safety and per-formance standards under a proposed US Food and

Drug Administration pilot project.The agency laid bare plans for the Accreditation Scheme for

Conformity Assessment (ASCA) in a 20 September draft guid-ance document. The pilot program is part of an ongoing effort to streamline and globally harmonize the device approval pro-cess by increasing reliance on international standards. It was ini-tially proposed under the most recent Medical Device User Fee Amendments, or MDUFA IV, and further informed by discussions at a May 2018 FDA public workshop. (Also see “Conformity And Confidence: US FDA Seeks To Build Trust In Pre-Market Standards Declarations With ASCA Pilot” - Medtech Insight, 25 May, 2018.)

MDUFA IV’s timeline requires the FDA to initiate the pilot by the end of 2020, and report on its viability by the end of 2022.

The guidance document explains that Declarations of Con-formity may not always answer all the FDA’s questions about device safety and performance, depending on the reliability of the lab, the details of the specific standard and the com-plexity of the device involved. “In some instances, testing may be repeated or revised based on FDA input. These interactions and requests for modifications in test methodology can result in delays and additional costs to provide FDA with the neces-sary confidence in a declaration of conformity for its intended purpose,” the guidance states. The ASCA pilot is intended to help address this scenario.

The agency further expects ASCA to help enhance confi-dence in device testing, promote premarket review consis-

tency and encourage the effective use of FDA resources, the guidance states.

MULTISTEP ACCREDITATION PROCESS Manufacturers, accreditation bodies, testing labs and FDA staff will all participate in the pilot, the guidance document states. Accreditation bodies can apply for pilot inclusion by emailing [email protected]. The agency hopes to make these accreditation decisions within 60 days.

Standalone testing laboratories based in the US, in-house lab-oratories at device manufacturers, and overseas labs would all be eligible for ASCA pilot program participation, the FDA says.

Under ASCA, the agency would recognize accreditation bodies for a specific scope of standards and testing. The ac-creditation bodies could then in turn accredit device testing laboratories for compliance with international standards, and accredited testing labs could apply to the FDA for ASCA accreditation.

The agency would accredit the labs via a two-step process. First, the agency would recognize the testing laboratory for the purposes of the ASCA pilot, identifying the scope of AS-CA-eligible standards and test methods for that laboratory. The FDA would then grant the lab ASCA Accreditation via a second step.

Once a lab is accredited, it could test devices for conformity with eligible international standards. If the device met the rel-evant standards, the manufacturer could use the test report to establish conformity as part of a premarket application.

The FDA has proposed nine standards be incorporated into the trial, of which seven concern biological evaluation of de-vices and two address basic safety and performance. They are:

• ISO 10993-4: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood;

• ASTM F756: Standard Practice for Assessment of Hemolytic Properties of Materials;

• ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity;

• ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization;

Standalone testing laboratories based in the US, in-house laboratories at device manufacturers, and overseas labs would all be eligible for ASCA pilot program participation.



• ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity;

• USP <151>: Pyrogen Test;

• ISO 10993-12: Biological evaluation of medical devices – Part 12: Sample preparation and reference materials;

• ANSI/AAMI 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential perfor-mance; and

• IEC 61010-1: Safety requirements for electrical equipment

for measurement, control, and laboratory use – Part 1: Gen-eral requirements.

The standards may change based on stakeholder feedback be-fore the pilot launches, the FDA notes.

The agency will hold a webinar on the pilot program on 28 October. Comments on the draft guidance are open at Regula-tions.gov under docket No. FDA-2019-D-3805-0001 through 23 December.


MedTech Europe’s Bisazza: How Expert Panel Delays Have Caused Uncertainty For CompaniesAMANDA MAXWELL [email protected]

P ublication of the European Com-mission’s Implementing Decision laying down rules for the desig-

nation of expert panels was the first es-sential step toward setting up so-called “expert panels”.

One of the critical roles of these ex-pert panels is to give an opinion on the clinical evaluation assessment re-port, which is compiled by the noti-fied bodies that assess new class III im-plantables and class IIb active devices intended to administer and/or remove a medicinal product.

But many fear the commission ma-

chinery is moving too slowly and that there is a risk that some of this high-risk, critical medtech equipment may not be compliant in time for the deadline of full application of the Medical Device Regu-lation (MDR) on 26 May 2020, regardless of the publication of this Implementing Decision having already taken place.

Among them is Oliver Bisazza, direc-tor of regulations and industrial policy at MedTech Europe, who explained to Medtech Insight why these expert panels are needed so urgently in the context of the MDR – although less so in the con-text of the IVDR – and what is needed

now to get them operational.He is far from alone in his concerns

about potential delays. With just over eight months to go until the full applica-tion of the MDR, Bassil Akra, VP of global strategic business development at Ger-man notified body TÜV SÜD, told Medtech Insight: “I think everything is coming too late and do not believe that they will find those independent experts on the market.”

Below, Bisazza explains why the current situation is holding back manufacturers who are ready to demonstrate compli-ance with the new regulations.




Medtech Insight: What is MTE’s opinion about the timing of the publication of the Implementing Decision on the designa-tion of expert panels?

Oliver Bisazza: The most important question is whether the panels will themselves be fully up and running by the end of the year – as we have been calling for – or whether the Medical Devices Coordination Group (MDCG) will use up the remaining months of the MDR transition period before mak-ing the panels operational. As to whether this gives enough time for the panels to be set up and conduct their work, this depends on how the practical implementation will be han-dled. We hear that the call for interest should come out “any day now,” and that the intention is to largely finalize the com-position of the panels by the end of 2019.

What is the urgency to have the expert panels set up?

Bisazza: According to an interpretation from the Compe-tent Authorities for Medical Devices (CAMD), it is not pos-sible before 26 May 2020 for certain innovative high-risk devices (i.e. those subject to the ‘clinical evaluation consul-tation procedure’), to be fully CE-marked against the MDR unless the expert panels exist. The continued absence of these panels is forcing industry to keep putting these in-novative products through the former Directive, even if the manufacturer has gone through the considerable work of getting files ready for submission to a notified body desig-nated under the MDR.

What about for IVDs?

Bisazza: For IVDs, the situation is a little different because the IVDR’s performance evaluation consultation procedure in-volving expert panels is only foreseen for those specific cases where a class D IVD (highest risk) is not covered by an IVDR common specification. Although no IVDR common specifica-tions exist yet, they are expected in the coming months for ‘most’ technology areas where they are needed. Our assess-ment has therefore always been that expert panels will only be needed for a very limited range of IVDs.

Is there any talk in the background about certain product areas being prioritized in terms of setting up these panels?

Bisazza: Not that we are aware of. For IVDs, as mentioned above, the product areas in scope are very limited. For medi-cal devices, Article 1 of the recently published Implementing Decision has confirmed 10 therapeutic areas for which the panels are being set up. To our understanding, these are of equal priority.

The experts are to receive €450 a day. Do you think applicants for these roles will mostly be clinicians who are actively pursuing

their jobs and giving additional time to being experts, or former industry consultants who might make this a full-time post?

Bisazza: From what we currently understand, advisors to these expert panels will probably not conduct these duties on a full-time basis. We expect that the number of actual opin-ions to be given each year will not be so big as to require these advisors to devote a significant amount of their time to these panels, even though the work on individual opinions may be quite intense while the 60-day period is ongoing. As to the profiles of the advisors themselves: the main criteria will likely be independence, impartiality and proven clinical experience with the technology in question.

Can you explain more about the role of the “additional” ex-pert panel?

Bisazza: There is a “12th panel” referred to in Article 1(2) of the Implementing Decision, which will be a sort of “triage” panel. This 12th panel will be in charge of deciding whether individual files meet the necessary criteria to be sent to the other panels, so that the clinical/performance evaluation consultations can be carried out. From what we hear, advisors to this 12th panel may span a range of clinical, technical and regulatory experience.

Lead medtech regulatory experts Bassil Akra and Gert Bos told me recently that work on the Clinical Evaluation Consultation Procedure could be undertaken by notified bodies until the ex-pert panels are appointed. Is this what is happening?

Bisazza: Based on the feedback we receive from manufactur-ers in the field, we do not really hear that this in happening in practice. The MDR states that notified bodies, after complet-ing their clinical evaluation assessment report, must transmit this document (and others, like the manufacturer’s clinical evaluation report) to the European Commission, which will then immediately transmit those documents to the relevant expert panels. The essence of the clinical evaluation consulta-tion procedure (CECP), therefore, is to have the expert panels verify the work done by the notified body in evaluating the clinical evidence provided by the manufacturer. We there-fore don’t see how the CECP itself could be carried out by the notified body. What we do hear from manufacturers is that (at least some) notified bodies are not even accepting MDR files right now, in respect of the interpretation given above, for products that are in the scope of the CECP. Or, they are accepting them but not doing anything with them yet. This is an alarming development, especially for manufacturers with highly innovative portfolios, and it underlines why we still urge the Medical Devices Coordination Group (MDCG) to ren-der the expert panels operational as soon as possible, and in any case before the end of 2019.



� C O M M E R C I A L �

LifePod Debuts ‘Proactive’ Voice Assistant Designed To Ease Elder CareMARION WEBB [email protected]

S tuart Patterson, CEO and co-founder of Boston, MA-based health IT start-up LifePod Solutions, is a firm

believer that its developed “proactive” voice-assistant caregiver is the wave of the future – as far as voice-assistant tech-nologies are concerned.

The company’s virtual caregiver is mak-ing its debut next month with a shipment of a thousand preorders to a health-care plan, senior-living facility and emergen-cy-response company, Patterson told Medtech Insight on 27 August at the Con-nected Health Summit in San Diego, CA.

“All virtual assistants over the past 50 years have been reactive,” Patterson said. “What we have introduced is the first proactive voice capability, where in the LifePod network and through the LifePod device, we can initiate the dialogue with the care recipient. And in the caregiving industry, that’s critical.”

The LifePod system differs from other voice services, such as Amazon’s Alexa

and Google’s Assistant, in that it doesn’t require a “wake” prompt or the pressing of a button. Instead, it uses a smart speak-er created by iHome and a web-based portal that is accessed by a caregiver to set up a scheduled routine. Caregivers can choose among preconfigured dia-logues, create personalized dialogues, or enter questions that require a “yes or no” answer by the care recipient, and then set times and dates for activation.

“You can set reminders for everyday medication, or reminders such as ‘Don’t forget it’s your son’s birthday,’ or a ques-tion that requires a yes or no answer such as, ‘Did you take your little red pill today?’ or reconfigure it to say, ‘Good evening Carol, it’s time for dinner, would you like to listen to Frank Sinatra?’” Patterson explained.

Caregivers typically preprogram nine to 10 dialogues a day – a combination of reminders, such as social, medical or health-related reminders, and check-ins. The LifePod service facilitates daily check-ins and notifies caregivers and family members in real time about how well the recipient is following the care plan.

Since the company was started by Pat-terson and Richard Lane in February 2017 with $1m in funding from the two found-ers and high net-worth individuals, the company has landed two strategic part-ners that are also clients, the Common-wealth Care Alliance and Mobile Health, raising its total financing to $6m. The monies will be used to continue develop-ment of the platform.

SEVERAL FRUITFUL PARTNERSHIPSLifePod announced in August a new collaboration with the American Heart Association’s Center for Health Technol-ogy & Innovation Innovators Network in a study that aims to explore the impact of LifePod’s services in helping heart-failure

patients adhere to their care plan. In particular, the study will investigate

whether LifePod can reduce costs by im-proving patient adherence to medication by offering reminders and also monitor-ing exercise habits in between doctor visits. Patients that fail to adhere to their medication plan contribute to roughly $300bn a year in avoidable health-care spending, LifePod says.

The company also joined forces with the Commonwealth Care Alliance, a Massa-chusetts health-care plan with more than 32,000 members, to run a three-month pi-lot study wherein they gave 52 members early editions of the voice system. The engagements provided alternatives to phone calls and in-person visits, resulting in cost reduction and reported high levels of satisfaction, LifePod said. The partners signed a new contract to extend the Life-Pod system to 500 new members.

Boca Raton, FL-based Mobile Health, which provides emergency response ser-vices to some 300,000 customers, also re-cently signed on with LifePod to connect seniors in their homes with LifePod’s voice-assistance to the emergency call center.

“They’ll be able to speak through the communicator with [Mobile Health’s] pro-fessionals in the call center, who will send

LIFEPOD 99 Summer St. Boston, MA 20110

Contact: Stuart Patterson

Founded: February 2017

Founders: Stuart R. Patterson, Richard Lane

Number of Employees: >10

Financing Total To Date: $6m

Investors: Commonwealth Care Alliance, MobileHealth, Inc., angel investors

Board of Directors: Stuart Patterson; Richard Lane; Charles Nichols II, Nichols Asset Management, LLC; Christopher Palmieri, CEO Commonwealth Care Alliance

Users will “be able to speak through the

communicator with [Mobile Health’s]

professionals in the call center, who will

send help.” – Stuart Patterson




Abbott Wins FDA Approval For ‘Low Dose’ Non-Rechargeable Spinal Cord Stimulator MARION WEBB [email protected]

A bbott Laboratories Inc. announced the US Food and Drug Adminis-tration approved the company’s

Proclaim XR spinal cord stimulator (SCS) for treating patients with persistent neuro-pathic pain. The device uses Abbott’s pro-prietary BurstDR technology, which offers patients low-dose pain management and runs on a battery that lasts up to 10 years without recharging, Abbott said.

The system is supported by results of the BurstDR micrOdosing StimuLation in De-novo (BOLD) study, in which 100% of the 24 enrolled patients on a low-energy BurstDR dosing program experienced pain relief with less than six hours of bat-tery use per day, while about 50% of those patients achieved pain relief with the low-est effective dose with less than two hours of battery use per day. Even at the high-

help,” Patterson explained.And, after a successful pilot study at

Needham, MA-based Windgate Healthcare skilled-nursing facility, LifePod will ship a hundred LifePods to their residents this fall. This month, HomeThrive, a concierge ser-vice, also contracted with LifePod to roll out its service to a hundred customers.

BUSINESS MODEL Under its business model, LifePod charges roughly $100 for the device and a monthly subscription fee of $30-$50 for the service. LifePod’s service is currently not reim-bursed by insurers, but Patterson has high hopes that the partnership with Mobile Health will pave the way to reimbursement.

Patterson said the technology platform continues to evolve. He envisions that the platform will eventually add question-naires and surveys, among other features. He noted that an insurance company inquired if the system could be used to monitor dementia patients by asking them the same questions three times a week and record responses.

Patterson and Lane originally acquired LifePod from Dennis Fountaine, a serial inventor who lives in San Diego. Patter-son said he and Lane learned about Life-Pod on a website and were immediately intrigued by the technology given the ris-ing popularity of smart speakers. Patter-son believed that Fountaine’s approach to

combine proactive voice assistance with home-monitoring capabilities that could serve the elderly or people with chronic disease would be ground-breaking.

Fountaine’s “brilliant idea was to say how could we take the Alexa interface and add the ability for the caregiver to control it and be proactive instead of being reac-tive,” Patterson said. “It supports the care-giver almost as much as the care recipient.”

LifePod has added a lot of brain power to the device in the last two and a half years, he added.

But the biggest challenge to date re-mains trying to communicate the ben-efits of a proactive device.

“We are marketing a new concept – something that’s never been done before – [which is] a device that’s set up by the caregiver, and that has been a challenge to get people to understand how differ-ent it is than what some 50 million people are using with Alexa every day,” Patterson

said. “Until you show them it’s working, they don’t believe it’s ever going to work.”

Patterson said $6m in funding is a lot of money, but like with any start-up, it’s critical to stay focused and try not to do too many things at once, “otherwise you’ll run out of time and money.”

He believes virtual assistance is the big-gest breakthrough in caregiving and that proactivity is the future.

“We call ourselves a ‘purpose-driven virtual assistant,’ as opposed to Apple Inc.’s Siri or Amazon’s Alexa and Google’s voice assistant, which are general-pur-pose virtual assistants with specialized capabilities,” Patterson said. “Amazon is specially capable in retail, Google is spe-cially capable in search, Facebook is spe-cially capable in communication – and we’re specially capable in caregiving.”

Patterson predicts we’ll see more fo-cused purpose-capable virtual assistants soon and believes that Facebook’s Portal is paving the way. It’s a virtual assistant and a device with a big screen that pro-vides video chat via Facebook Messenger and is integrated with Amazon’s Alexa.

“In the future, we’ll see a specially fo-cused purpose-capable virtual assistant and you’ll be able to say, ‘I need a virtual assistant for caregiving,’ and it’ll say, ‘Hold on, I will download LifePod for you.’”


LifePod dashboard



est settings, the systems were still in use only 25% of the time. The data from that trial was presented at the North American Neuromodulation Society (NANS) meet-ing and the International Neuromodula-tion Society (INS) earlier this year.

Jacqueline Weisbein, a pain specialist at the Napa Valley Orthopaedic Medical Group in Napa Valley, CA, and an Abbott consultant, has been using Abbott’s Pro-claim device with the BurstDR technolo-gy. She told Medtech Insight she adopted the dosing protocol from the BOLD trial after seeing the benefits.

“The BurstDR waveform delivers elec-trical packets in bursts that replicate the body’s natural nerve signaling patterns,” she said. The therapy works by deliver-ing low doses of mild electrical pulses to change pain signals as they travel from the spinal cord to the brain. The delivery of lower doses of stimulation helps save the system’s battery life, which allows in-dividuals to get pain relief without having to worry about recharging the device.

Jay Shah, CEO and executive medical director at the SamWell Institute for Pain Management in Colonia, NJ, also touted the benefits of BurstDR stimulation.

“BurstDR spinal cord stimulation can be a fantastic treatment option for well-selected patient candidates,” Shah told Medtech Insight. “There is great real-world evidence supporting the efficacy of its use for a variety of neuropathic or nerve pain related conditions, such as residual pain after neck or back surgery, as well as complex regional pain syndrome. Burst-DR has also been shown to be clinical effective in treating those patients who have a coinciding pain related anxiety or depression.”

RECHARGING BATTERY IS A BURDENRecharging the battery is a huge burden on patients, Weisbein said.

“The reality is a lot of patients don’t re-alize that their device might turn off if it’s rechargeable,” she said. “Sometimes pa-tients forget to charge their battery be-cause they are busy and living their lives.”

Abbott’s Proclaim XR frees patients from having to recharge batteries. Other

devices require patients to recharge their batteries daily or every three days, which means sitting still for 30 minutes to an hour until the battery is charged, she said. Studies have shown that recharge-able devices are removed twice as often as recharge-free devices.

Shah agreed that the recharge-free system is a major benefit to patients, but stressed that proper patient selection is key.

“The art of patient care is in finding the right therapy for the right patient, whether that be a technology that offers a rechargeable versus non-rechargeable option,” Shah said. “Depending on the frequency of use, non-rechargeable sys-tems typically need replacing after seven to 10 years of use and newer rechargeable systems typically require daily or weekly charging.” (Also see “Market Intel: Pain Man-

agement II: Competition Intensifies For Spi-nal Cord Stim Market’s Big Three” - Medtech Insight, 23 May, 2017.)

Weisbein added: “Stimulation has changed in the last five to 10 years, where patients are no longer feeling the stimula-tion that they felt with tonic stimulation, the traditional stimulation where patients experience paresthesia, or a tingling sen-sation to mask the pain.”

Abbott sponsored an earlier study, SUN-BURST, that showed that 70.8% of patients preferred burst stimulation; 91% of pa-tients reported experiencing less pares-thesia during treatment with burst as op-posed to tonic. Some patients still want to have the option of tonic stimulation, which the Proclaim XR system can also deliver.

Abbott won FDA approval in October 2016 for its BurstDR technology, which can deliver both burst and tonic stimulation, and is being used in its Proclaim, Prodigy and Protégé SCS systems.

Abbott ranks among four key players in the growing neuromodulation market. The others are Medtronic PLC, Boston Sci-entific Corp. and Nevro Corp. According to Meddevicetracker, worldwide sales of SCS systems will climb from $1.8bn in 2016 to $2.4bn in 2021, a CAGR of 6%. (Also see “Market Intel: NANS 2018: Positive Data In-tensifies Spinal-Cord Stim’s Big-Four Rivalry” - Medtech Insight, 5 Feb, 2018.)

Weisbein noted that the Proclaim XR stands apart from competitors, because it is the only device with a non-rechargeable battery that lasts up to 10 years.

“None of the other companies can offer that in a non-rechargeable battery – their rechargeable batteries might last 10 years, but will require frequent recharging.”

The device is programmed by the physician to meet each patient’s spe-cific stimulation needs for pain relief and comes with an iPod for the patient to con-trol the device.

Weisbein said the first patient will be im-planted with the device on 25 September. The company is conducting a limited mar-ket release now and expects to launch Pro-claim XR in the US on 30 September. Abbott doesn’t disclose sales forecasts.


Sour

ce: A

bbot

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Proclaim XR neurostimulator

“The art of patient care is in finding the right therapy

for the right patient, whether that be a

technology that offers a rechargeable vs non-rechargeable option.”

– Jay Shah



� R & D �

Feasibility Trial Of Medtronic’s Intrepid Transfemoral TMVR BeginsREED MILLER [email protected]

M edtronic PLC is sponsoring a fea-sibility study of its Intrepid trans-catheter mitral valve replacement

system delivered through the transfemoral approach in patients with severe, symptom-atic mitral regurgitation who are ineligible for open mitral valve surgery.

The US Food and Drug Administration approved the study for up to 15 patients at up to six centers, Medtronic announced on 27 September. Follow-up evaluations are planned for one, three, six and 12 months, and then every six months after that for up to five years. The company hopes to com-plete the trial in 2020.

Mitral regurgitation is the most common type of heart-valve defect in the US, afflict-ing about 4 million people. If left untreated, mitral regurgitation exacerbates heart fail-ure, but there are currently few treatment options for patients with mitral regurgi-tation who are not candidates for open surgery.

Intrepid has a self-expanding, dual-stent frame supporting a tissue valve designed to be installed directly into the native mi-tral valve to restore normal blood flow without mitral regurgitation. It is based on technology Medtronic acquired when it bought Twelve Inc. for $458m in 2015. (Also see “Starts & Stops: Medtronic’s TMVR News Closes Big Month For Trial Announcements” - Medtech Insight, 3 Nov, 2017.) Medtronic is also currently sponsoring the landmark APOLLO trial, which is randomizing patients to moderate to severe or severe symptom-atic mitral regurgitation to open valve sur-gery or transcatheter mitral valve replace-ment with Intrepid. The 1,380-patient trial will also have a non-randomized arm of pa-tients treated with Intrepid because they are not candidates for surgery.

ADVANTAGES OF REPLACEMENT VERSUS REPAIRAbbott’s MitraClip is the only FDA-ap-proved transcatheter mitral repair de-

vice. Medtronic is among several com-panies developing transcatheter mitral valve repair or replacement devices, including Neovasc Inc., LivaNova PLC, Kephalios, Edwards Lifesciences Corp. and Boston Scientific Corp. (Also see “Market Intel: Relentless Rise Of Transcath-eter Tech: Heart Valve Repair Turns Back On Open Surgery” - Medtech Insight, 24 Jul, 2017.)

Pieter Kappetein, Chief Medical Officer for Medtronic’s structural heart busi-ness, told Medtech Insight that mitral valve replacement has the potential to reduce mitral valve regurgitation more effectively than mitral valve repair. “The transcatheter mitral replacement system replaces the valve and reduces the mi-

tral regurgitation to zero. With MitraClip, you often still have a grade 2+ [mitral regurgitation] left,” Kappetein said. “The reason is that it’s harder. It’s a more dif-ficult way of repairing the valve.”

Kappetein said Medtronic’s trans-catheter mitral valve “is pretty easy to deploy. It’s technically not very difficult. Therefore, we think the learning curve for placing it is not as steep as it is for the MitraClip.” The transcatheter mitral valve is also easier to deploy than transcath-eter aortic valves because aortic valves are generally more calcified than mitral valves, he said. Medtronic is sponsoring a registry study of patients with calcium in their mitral valve, who are especially difficult to treat.

TRANSFEMORAL VERSUS TRANSAPICALThe design of the feasibility trial of the transfemoral approach – via a catheter run through the femoral artery – builds on the findings of the 50-patient Intrepid TMVR pilot study, which evaluated In-trepid implanted transapically – through a thoracotomy in the chest and through the apex of the left ventricle.

The Intrepid TMVR Pilot study was the first trial approved by the FDA to evalu-ate the safety and efficacy of a trans-catheter mitral valve system, according to Medtronic. In that trial, the 30-day mortality rate was 14%, with no disabling strokes, or repeat interventions. After a median follow-up of 173 days, mitral re-gurgitation was either mild or undetect-able in all of the patients treated with Intrepid. Almost 80% of the patients showed improvements in their heart-fail-ure symptoms, as measured by New York Heart Association functional class. The patients’ average Minnesota Heart Failure Questionnaire score improved from 31.7 to 56.2 over 12 months.

The transapical approach is less inva-

“Transapical is

better than open

heart surgery,

where you

have to stop the

heart which is

already in a bad

condition. [But]

transfemoral is less

invasive than the

thoracotomy.”

– Pieter Kappetein


� R & D �

sive than open heart surgery, but is still a very invasive procedure, Kappe-tein said. “If you don’t have any other approach, it’s great to give [patients] at least an alternative to open sur-gery, where you also have to arrest the heart,” he said. “In that respect, trans-apical is better than open heart surgery, where you have to stop the heart which is already in a bad condition. [But] transfemoral is less invasive than the thoracotomy.”

He pointed out that, unlike transfem-oral aortic valve replacement, in which the catheter accesses the heart through the arterial system, transfemoral mitral valve replacement accesses the heart through the venous system, which is more flexible and not as calcified.

The company is planning a second generation version of Intrepid that will have a narrower delivery catheter. “We hope that eventually we can get our system so small that we can treat all patients transfemorally, but we’ll have to see,” Kappetein said. The cur-rent Intrepid delivery system is 35 Fr, “which is big,” he added.

Most patients can be safely treated with a delivery system this large, but it may be too big for some smaller patients, he said. In the Intrepid transfemoral feasibility trial, all of the patients will be evaluated with computed tomography to measure the size of their vessels to ensure they can accommodate the 35 Fr system, he said.

Martin Leon of Columbia University, the co-principal investigator of the transfemoral feasibility trial, said: “We are optimistic about the potential ben-efits of the transfemoral approach for mitral valve replacement – which is less-invasive than the transapical tech-nologies currently in pivotal trials. The early clinical results we have seen with Intrepid and this early feasibility study advances the TMVR field as we look for less invasive ways to treat this patient population, of which a large propor-tion are considered too high risk for surgery.”


TCT 2019: Boston Scientific’s Acurate Neo TAVR Misses Endpoint In SCOPE IREED MILLER [email protected]

E arly results from the SCOPE I trial showed Boston Scientific Corp.’s Acurate neo trans-catheter aortic valve performed worse than Edwards Lifesciences Corp.’s Sapien 3 valve.

Although the SCOPE I results are disappointing for the company, Boston Scientific remains committed to the Acurate neo platform as well as its Lotus Edge TAVR system, which was approved by the US Food and Drug Administration in April. (Also see “Boston Scientific Becomes Third US TAVR Competitor With Lotus Edge Approval” - Medtech Insight, 24 Apr, 2019.)

“The SCOPE I trial adds to the breadth of available clinical evidence supporting the Boston Scientific dual-valve portfolio comprised of the Acurate neo valve and Lotus Edge aortic valve system,” the company said in a statement. “SCOPE I confirmed that the Acurate neo platform facilitates significantly optimized blood flow compared with Sa-pien 3, and, consequently, lower rates of patient anatomy mismatch that may contribute to negative long-term clinical outcomes.”

DIFFERENCE DRIVEN BY PARAVALVULAR LEAKPrimary investigator Jonas Lanz of Bern University Hospital in Switzerland presented the 30-day outcomes from SCOPE I at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco on 27 September, and the results were simultaneously pub-lished in The Lancet. (Also see “TCT 2019: A Preview Of Late-Breaking Trials; Analyst Expecta-tions “ - Medtech Insight, 18 Sep, 2019.)

Acurate neo is a self-expanding transcatheter aortic valve replacement system de-signed to be installed in the supra-annular position – above the valve annulus – while Sapien 3 is a balloon-expandable valve designed to be installed in the intra-annular po-sition. Boston Scientific acquired the Acurate neo technology when it bought Symetis SA for $435m in 2017. (Also see “Symetis TAVR Buy Not About Throwing Shade On Lotus, BSX Insists” - Medtech Insight, 30 Mar, 2017.)

SCOPE I randomized 739 patients with symptomatic severe aortic stenosis at increased surgical risk to transcatheter aortic valve replacement with Acurate neo or Sapien 3 at 20 centers in Europe. The primary endpoint was a composite of death, stroke, life-threaten-ing or disabling bleeding, major vascular complications, coronary artery obstruction re-quiring intervention, acute kidney injury, rehospitalization for valve-related symptoms or congestive heart failure.

The trial was designed to show Acurate neo is non-inferior to Sapien 3 in the inten-



� R & D �

tion-to-treat population on the basis of a risk-difference margin of 7.7% for the primary endpoint at the 30-day follow-up.

At the 30-day follow-up, the primary endpoint occurred in 24% of the patients treated with Acurate neo and 16% of patients treated with Sapien 3, so Acurate neo did not meet the primary non-inferiority endpoint. The secondary analysis of the primary endpoint suggested Sapien 3 is superior to Acurate neo for the primary endpoint.

The Acurate neo and Sapien 3 groups had similar rates of all-cause death – 2% versus 1%, respectively – and stroke – 2% ver-sus 3%, but acute kidney injury was significantly more common in the Acurate neo group than in the Sapien 3 group – 3% versus 1%. Moderate or severe prosthetic aortic regurgitation was also

more common in the Acurate neo group than the Sapien 3 group – 9% versus 3%. However, follow-up echocardiography showed the median mean transvalvular pressure gradient was lower and the median mean aortic valve area was larger with Acurate neo versus Sapien 3.

The rate of permanent pacemaker implantation was low and simi-lar in both groups – 12% with Acurate neo and 10% with Sapien 3.

The difference in the primary endpoint was driven mainly by the significantly worse rate of paravalvular aortic regurgitation in the Acurate neo group compared to the Sapien 3 group, the authors said. Previous studies have shown paravalvular aortic regurgitation is linked to worse overall prognoses for patients, Lanz and colleagues explain in The Lancet.

Potential factors contributing to the greater paravalvular re-gurgitation in the Acurate neo group compared to the Sapien 3 group include differences in the structure of the devices’ sealing skirts and the lower radial force provided by the Acurate neo de-vice, Lanz et al. explain. “An iteration of the Acurate neo valve fea-turing an advanced sealing skirt could further mitigate the risk of paravalvular regurgitation, and requires further evaluation,” the authors suggest.

Acute kidney injury may have been more frequent in the Acu-rate neo group than in the Sapien 3 group because implantation of Acurate neo required a significantly longer average procedure time. Acurate neo also required pre-dilatation and post-dilatation more often than the Sapien 3, and therefore more contrast solu-tion, the authors point out.

“The clinical relevance of the lower residual transvalvular gra-dients and greater effective orifice areas observed with the su-pra-annular Acurate neo compared to the intra-annular Sapien 3 valve remains to be elucidated,” they conclude.

BOSTON SCIENTIFIC REMAINS CONFIDENT IN BOTH ITS TAVR SYSTEMSDuring Boston Scientific’s scientific symposium at the TCT con-ference on 27 September, Kevin Ballinger, president of the com-pany’s interventional cardiology business, said the SCOPE I re-sults are “a headwind” for sales of Acurate neo, but “I don’t view it as an enormous headwind.”

He pointed out that about 20,000 patients have been im-planted with Acurate neo in Europe. “There is a really rich experience set. The physicians that use neo really have their own large rich patient sets and they know the performance of that device and generally, where it is used, it’s one of the pri-mary valves [they implant],” he said. “That overarching point of 20,000 patients worth of individualized experience is going to win the day.”

Ballinger said that sales of Acurate neo may “flatten out a bit,” but have been growing 30% to 40% year-over-year in recent quarters, and he sees additional growth opportunities for Boston Scientific’s TAVR systems in Europe.

He pointed out that Boston Scientific sells its TAVR system with its Sentinel embolic protection device, the only FDA-cleared em-bolic protection device specifically indicated for TAVR. (Also see “Three Devices Gain Medicare Add-Ons, Including Boston Sci’s New TAVR Protector “ - Medtech Insight, 3 Aug, 2018.)

“Now we’ve got the healthy production levels of Sentinel, so we can be more aggressive in terms of commercial bundles in Europe,” he said. “And you get through the summer months in Europe and you can really start to work more deals.”

ACURATE NEO2 ADDRESSES SHORTCOMINGS OF ACURATE NEOBallinger predicted that the company’s next-generation Acu-rate neo2 TAVR system “will certainly improve” upon the para-valvular leak performance of Acurate neo seen in SCOPE I. He reiterated the company’s expectation that it will launch neo2 in Europe in mid-2020. (Also see “Boston Scientific Delivers Q2 Sales Growth Across Its Product Lines” - Medtech Insight, 25 Jul, 2019.)

The company is sponsoring the 600-patient ACURATE IDE trial in the US, comparing the Acurate neo2 TAVR system to Medtronic PLC’s CoreValve TAVR system and Sapien 3. Ac-cording to the company, Acurate neo2 maintains the key features of the original Acurate neo, while adding an an-nular sealing technology to reduce paravalvular leak. Acu-rate neo2’s delivery system also includes a new radiopaque marker to make it easier for the implanting interventionalists to optimize the position of the replacement valve within the native valve’s annulus.

Results of the single-arm Acurate neo2 CE-mark study, pre-sented at the PCR London Valves meeting in September 2018, showed a 97.5% procedural success rate. At the 30-day follow-up, 3% of patients had moderate paravalvular leak while the rest had mild or no paravalvular leak.


The SCOPE I results are “a headwind” for the commercial potential of Acurate neo, but “I don’t view it as an enormous headwind.” – Kevin Ballinger


� R & D �

TCT 2019: IDEAL LM Inconclusive, While Onyx ONE Boosts Polymer-Based DESPHIL GREENFIELD [email protected]

R esults of the IDEAL LM trial showed patients with left main coronary artery disease treated with Boston Scien-tific Corp.’s Synergy everolimus-eluting platinum-chro-

mium stent with a biodegradable polymer fared equally well with short-duration dual antiplatelet therapy (DAPT) as pa-tients treated with Abbott Laboratories Inc.’s Xience everoli-mus-eluting cobalt-chromium stent and a standard 12-month course of antiplatelet therapy.

Robert-Jan Van Geuns, from Erasmus Medical Center in Rot-terdam, reported the results on 26 September at the Trans-catheter Cardiovascular Therapeutics (TCT) meeting in San Francisco. IDEAL LM was conducted at 29 sites across six coun-tries between 2014 and 2016. Investigators randomized 818 patients to intervention with Synergy and four months DAPT or Xience and 12 months DAPT. (Also see “TCT 2019: A Preview Of Late-Breaking Trials; Analyst Expectations “ - Medtech Insight, 18 Sep, 2019.)

The 12-month rate of major adverse cardiac events – a com-posite that included all-cause mortality, myocardial infarction, and ischemia-driven target vessel revascularization – was 14.6% in the patients treated with DAPT for four months fol-lowing implantation with Synergy, and 11.4% in the patients treated with DAPT for 12 months after receiving the Xience stent. The difference did not meet statistical significance.

While the IDEAL LM researchers said the trial “confirms the excellent outcome of current angioplasty techniques in left main coronary artery disease” and that short-term DAPT is an “also an option in the left main subset” of patients with the latest drug-eluting stent design, some experts not involved with the study doubt those conclusion.

Multiple secondary endpoints, including myocardial infarc-tion, ischemia-driven target vessel revascularization, and def-inite/probable stent thrombosis, were roughly double with Synergy and short-duration DAPT compared with Xience and 12-month DAPT. Bleeding was also significantly higher with Synergy and short-duration DAPT compared with Xience and a longer DAPT course.

Robert Harrington from Stanford University cautioned against the IDEAL LM investigators’ interpretation of the data during the press conference announcing the trial. “The failure to observe a difference is not the same as there being no dif-ference. In fact, as has been said, all of the data is suggesting there is somewhere in range of doubling of risk. I don’t think you should conclude that this is an option. I think you should conclude this is worrisome, and more data is needed.”

Speaking to media after the press conference, Vijay Kunadi-an, of Newcastle University in the UK, said she was uncertain

what to do with the IDEAL LM results when she returns home to clinical practice, noting the trial compares two different stents and two pharmacologic approaches, which makes in-terpreting the findings difficult.

Less confusing were results from Onyx ONE, which found that in coronary intervention patients at high risk for bleed-ing, a polymer-based drug-eluting combined with one-month dual antiplatelet therapy (DAPT) is noninferior to a polymer-free drug-coated stent combined with the same DAPT regi-men, and may confer better angiographic outcomes. The findings suggest that lower-cost polymer-based drug-elut-ing are as effective as their more-expensive polymer-free counterparts.

Stephan Windecker from University Hospital in Bern pre-sented findings from the Onyx One global randomized trial that randomized up to 2,000 high-bleeding risk patients to receive either Medtronic PLC durable-polymer Resolute Onyx drug-eluting stent or Biosensors International Group Ltd.’s polymer-free BioFreedom drug-eluting stent with one month of dual antiplatelet therapy.

While polymer-free drug-eluting stents in combination with one-month DAPT has shown superior safety and efficacy out-comes compared with bare-metal stents among high-risk bleeding patients, the Onyx ONE study is the first study to di-rectly compare a durable polymer stent with a polymer-free drug- eluting stent in that patient population.

Windecker and colleagues found that for the primary compos-ite safety endpoint of cardiac death, MI, and definite/probable stent thrombosis at one year, the Resolute Onyx stent was nonin-ferior to the drug-coated BioFreedom stent – 17.1% versus 16.9%.

There were no differences between the stents for the combined secondary effectiveness endpoint of target lesion failure at one year. Event rates were driven by similar rates of target-vessel MI in both groups – 12.8% for Resolute Onyx versus 14.0% for BioFree-dom. However, there was a significantly lower incidence of target-vessel myocardial infarction with the Resolute Onyx – 3.7% versus 5.9%. In addition, Resolute Onyx demonstrated better acute per-formance with a success rate of 92.8% versus 89.7% for BioFreedom.

Speaking in a press conference announcing the results, Marco Valgimigli of the University of Bern in Switzerland, said the study “for the very first time allows us to know that the Onyx stent is a very viable and reasonable option.”

However, Onyx ONE’s limitations include it being a single-blinded trial that was not powered for low-frequency events and which lacked a longer-duration DAPT control arm.



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