aortic stent grafts – eu analysis and …continued concern for high priced medical devices across...

REFERENCE CODE GDME1117CFR | PUBLICAT ION DATE OCTOBER 2014

AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS

Aortic Stent Grafts – EU Analysis and Market Forecasts 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.


Executive Summary

Table below provides the key metrics for aortic

stent grafts in the 5EU (France, Germany, Italy,

Spain, and UK,).

Aortic Stent Grafts, Key Metrics in Major Markets (2013) Procedure Volume of Abdominal Aortic Aneurysms 24,773

(2013) Procedure Volume of Thoracic Aortic Aneurysms 5,981

5EU $288m

Key Events (2012–2019) Impact

(2014) Cordis Corporation of Johnson & Johnson; the INCRAFT endograft is currently undergoing clinical trials in Europe, Japan, and the US; it is expected to be approved in 2014, 2018, and 2017 in each of the territories, respectively.

↑↑↑

(2014) Strong expectation from Endologix to continue to acquire more market share, thereby slicing into the top three players’ shares.

↑↑↑

(2014) Medtronic to acquire Covidien for $42.9bn, which can result in cuts in their endovascular business.

↑↑

(2014) Strong pipeline of stent grafts with good pipeline products from Asian and Western players. ↑↑

Competitive Assessment

Number of Devices in Marketing Phase 56

5EU $445m

Source: GlobalData; primary research interviews with leading vascular surgeons in 5EU 5EU = France, Germany, Italy, Spain, and UK

Sales for Aortic Stent Grafts

The total aortic stent graft sales market in 2013

was estimated to be $288m across the 5EU.

By the end of the forecast, the stent graft sales

market will grow to over $445m, with a Compound

Annual Growth Rate (CAGR) of 6.4%.

The key drivers for the market in the forecast are:

The growing prevalence of aortic aneurysms

along with the aging population across the

globe with hypertension and obesity.

The growing technological advancement in

minimally invasive procedures and the desire

to eliminate the need for open surgical

procedures for aneurysms.

The major underserved population for

minimally invasive aneurysm treatment in the

emerging markets that is driving the procedural

numbers up.

The unmet need for better clinical outcomes

and long-term studies to reduce the risk of

endoleaks and other complications.



Executive Summary

Figure below depicts the projected growth revenue

for aortic stent grafts in the 5EU from 2013 to

2020.

Aortic Stent Graft Revenue by Major Market (2013–2020)

18%

35%27%

8%

12%

France

Germany

Italy

Spain

UK

2013$288m

18%

35%28%

8%

11%

2020$445m

Source: GlobalData; primary research interviews and surveys with leading vascular surgeons in the 5EU

The European Union (EU) forms about 24% of the

global share in 2013. The EU is technologically the

most advanced market, with the best availability of

fenestrated and custom stent grafts on the market.

The emerging markets see the most open surgical

procedures, but stent use is restricted due to the

cost of the products and procedures. As training

programs for surgeons increase and product prices

decrease, the emerging markets will present a

strong opportunity for additional revenue for

manufacturers. The overall CAGR across all EU

markets is 6.4%, with XYZ representing the biggest

growth opportunities. The growing concerns for

multinational companies reside with the need to

better target the fast-growing markets and the

need to continue to be the leader in development

to combat the threat of rising local manufacturers.

Technological Trends

Within the last twenty years, endovascular

products have dramatically changed with

development relating to improved navigation,

trackability, and flexibility, as well as with the

stability of access, especially through tortuous

anatomy. Imaging technology has had an immense

impact on the treatment rates and detection of

aneurysms as well. The advances in ultrasound

technology have greatly reduced the incidence of

aneurysm rupture. As a result of better detection,

there can be earlier intervention and fewer open

surgeries, thereby resulting in more stent graft

placement.



Executive Summary

The technological developments in endovascular

repair will essentially continue to result in positive

growth. The primary technological drivers include

the development of ultra-low profile systems to

access difficult anatomies and arteries that are

smaller in diameter. The customized fenestrated

products have provided a major opportunity for

physicians to treat a new patient pool that was only

subject to open repair. Thoracic endovascular

aneurysm repair (TEVAR) is also an area that is

still in its infancy, thus yielding low procedure

numbers. As there is more development in those

product lines and as the abdominal aortic stent

graft product matures, there can be a strong

platform for development in the abdominal market

as well. Generally, there is still much room for

development in endovascular aortic repair (EVAR)

and TEVAR, and as the products evolve, there will

be continued growth in this market.

Unmet Needs Remain a Challenge

The complications in endovascular repair usually

occur during or immediately after the procedure,

which must be treated immediately through either

interventional or open surgery methods. Endoleaks

are the most common complication and area of

focus; the remaining complications, such as

paraplegia, infection, and limb thrombosis,

amongst others, occur from time to time and

knowledge of them can help enhance future

product design.

Technological challenges also pose an opportunity

for the development of better products with better

clinical outcomes. The availability of lower profile

systems will continue to improve accessibility.

Customized fenestrated stent grafts will allow more

complicated aneurysms to be treated, thereby

enhancing the potential patient pool. Multi-

branched systems will also allow for more tortuous

anatomy to be treated. Finally, addressing the

need for more long-term clinical data will allow

more surgeons to be comfortable implanting stent

grafts, with the assurance of durability in younger

patients.

Key Players in the Aortic Stent Graft Market

At present, the aortic stent grafts market is still

dominated by the top three players: Cook Medical,

Gore Medical, and Medtronic. The products that

are currently approved and on the market are all of

high quality and each have their strengths with

fixation types. The products in development by

those outside of the top three players are all

innovative in their own way, but a product that will

show superior benefits with a lower or at least

equal cost will be the one to grow the most.

The most talked about emerging player in the

market, based on GlobalData’s key opinion leaders

(KOLs), is Endologix. Endologix has one of the

strongest product pipelines with significantly new

product features and a new approach to treatment

that has the potential to grab a piece of market

share. The next one to three years will determine

the quality of the potential products for Endologix,



Executive Summary

based on approval and clinical trials. In the EU, the

top 82% of the EVAR market and top 92% in

TEVAR market belongs to the three companies

mentioned earlier. The ongoing trend in the aortic

stent grafts market is that the leading players will

continue to maintain market share, unless a

disruptive technology in this segment dramatically

changes clinical outcomes.

Aortic Stent Graft Market Future Outlook

The economic downturn has been a source of

continued concern for high priced medical devices

across the global market. The aortic stent grafts

market is not one that is excluded from this trend.

Despite the high product price, physicians still see

a significant benefit in providing endovascular

options versus performing open surgery. As

physician education improves and they have

access to more clinical trial data, the outlook for

the aortic stent grafts looks strong with there being

much room for product improvement.

The market outlook looks strong in the Western

markets, as there is still much room for product

adoption and growth. Regionally, one can expect

slightly different drivers for growth.. In some

countries, the EU market is still restricted by cost,

thereby making physicians choose their patients

carefully before implantation of the device.

The aortic stent grafts market is a moderately

growing market at a CAGR of 6.7% in EU, with

some individual markets boasting a stronger

CAGR over others. Within the 5EU, it is the

cardiovascular sector that is expected to continue

to grow the most in response to the continual

technological developments and physicians’

acceptance of the products’ successful clinical

performance. The EU market is based on, and will

be driven by, the rising prevalence of aortic

aneurysms and the aging population.

GlobalData expects continued growth in this niche

market with the major deterrent, globally, to be

product price once a product is accepted by a

surgeon.

What Do Physicians Think?

Physicians expect the cost of implants to be a

growing concern for practices and hospitals.

“Cost is a major issue all across the board,

specifically here. We try to do everything with the

least cost possible. So, if the grafts are exactly the

same and treat the same problem, then we try to

use the graft that's cheaper.”

Key Opinion Leader

“In an economic downturn, we need to be able to

show that what we do is cost-effective. Many

hospitals, for example, have capped down the

number of procedures that can be done in a year.”

Key Opinion Leader



Executive Summary

With regard to the technological trends and

product enhancement expectations, KOLs

speak on what is needed the most today.

“Smaller sheath size, introduction diameter. And

the reason being, is that a major limitation is the

size of the external iliac arteries, disease there, not

allowing you to pass the stent graft up. Lower-

profile delivery devices, which are also in trial.

Actually, they're not on trial. For many companies,

they're brand-new.”

Key Opinion Leader

Physicians discuss government regulations

where reimbursement plays a big part in

choosing to do endovascular repair

procedures.

“We use the product we think we need. The

expensive price is limiting our activity, of course.

So, we have to choose the product by indication.

So, we cannot use these products. More patients;

[we] have to select the best patients to use on this

because of the price, sure.”

Key Opinion Leader

Physicians are interested in solid clinical

studies to prove outcomes in products.

“In all honesty, the specific product features don't

matter as much as the trials that show whether a

device is durable or not. Everyone has their little,

‘We have a hook here,’ and other people have the

supra-aortic stents. ‘We have ones with hooks,

ones without hooks. We have screws that go into

the aortic wall.’ The reality is, unless there's some

sort of published data, everything else is just

theoretical. And to me, that doesn't matter.”

Key Opinion Leader

Physicians talk about the shift from open

surgery to endovascular repair.

“In the smaller hospitals where you have older

surgeons who didn't have endovascular training,

those are the ones who need more experience with

the devices than people like myself, who've been

out about four or five years.”

Key Opinion Leader

“[The] endovascular device, we would use that

almost exclusively, except in super young patients.

Patients less than 60, we offer an open operation

just because it's durable. Technically speaking,

you're fixing the problem both ways. It's just that

we know that open will last 30, 40 years. We still

don't know that about endovascular.”

Key Opinion Leader


Table of Contents


1 Table of Contents

1 Table of Contents ....................................................................................................................... 7

1.1 List of Tables .................................................................................................................... 15

1.2 List of Figures ................................................................................................................... 20

2 Introduction ............................................................................................................................... 21

2.1 Catalyst ............................................................................................................................. 22

2.2 Related Reports ................................................................................................................ 23

2.3 Upcoming Related Reports ............................................................................................... 23

3 Industry Overview ..................................................................................................................... 24

3.1 Overview ........................................................................................................................... 24

3.2 Indications ......................................................................................................................... 25

3.2.1 Aortic Abdominal Aneurysm .......................................................................................... 25

3.2.2 Thoracic Aortic Aneurysm ............................................................................................. 26

3.2.3 Aortic Dissection ........................................................................................................... 27

3.3 Clinical Outcomes ............................................................................................................. 28

3.3.1 Lifestyle Changes .......................................................................................................... 29

3.3.2 Medication ..................................................................................................................... 30

3.3.3 Open Surgery ................................................................................................................ 30

3.3.4 Endovascular Repair ..................................................................................................... 31

3.4 Procedure Trends ............................................................................................................. 33

3.4.1 EU ................................................................................................................................. 33

3.5 Market Access .................................................................................................................. 35


Table of Contents


3.5.1 Adoption ........................................................................................................................ 36

3.5.2 Regulation ..................................................................................................................... 41

3.5.3 Reimbursement ............................................................................................................. 42

3.6 Regulatory Issues/Recalls ................................................................................................. 48

3.6.1 Anaconda Back on the Market in March 2014 after a Voluntary Recall of Anaconda by

Vascutek ...................................................................................................................... 48

3.6.2 Terminated FDA’s Class II Recall of TriVascular’s Ovation Prime in April 2014 ............. 48

3.7 Mergers, Deals, and Acquisitions ...................................................................................... 48

3.7.1 Medtronic Acquires Covidien ......................................................................................... 48

3.7.2 TriVascular Launches $100m Initial Public Offering....................................................... 49

3.7.3 Lombard Medical Pursues US Initial Public Offering ...................................................... 49

3.7.4 TriVascular Raises $40m in Series E Financing ............................................................ 49

3.7.5 LifeTech Scientific Creates Partnership with Medtronic ................................................. 49

3.7.6 LeMaitre Vascular Terminates Distribution Agreement with Endologix .......................... 49

3.7.7 Jotec Enters Licensing Agreement with Hydromer ........................................................ 50

3.7.8 Endologix Public Offering of Notes ................................................................................ 50

3.7.9 Aptus Endosystems Secures Financing ........................................................................ 50

3.7.10 Altura Medical Secures Financing ................................................................................. 50

3.7.11 Endologix Acquires Nellix Endovascular ........................................................................ 50

3.8 Economic Impact .............................................................................................................. 51

3.8.1 Economic Impact of Aneurysms .................................................................................... 51

3.8.2 Treatment Costs of Aortic Aneurysms ........................................................................... 52

4 Unmet Needs ............................................................................................................................ 54


Table of Contents


4.1 Addressing the Complications ........................................................................................... 54

4.1.1 Endoleaks ..................................................................................................................... 54

4.1.2 Ischemic Complications ................................................................................................. 55

4.1.3 Limb Thrombosis ........................................................................................................... 56

4.1.4 Infection ........................................................................................................................ 56

4.1.5 Paraplegia in Thoracic Aortic Aneurysm ........................................................................ 56

4.2 The Seal and Landing Zone .............................................................................................. 57

4.3 Short Neck ........................................................................................................................ 58

4.4 Cost Containment ............................................................................................................. 59

4.5 More Low Profile Systems................................................................................................. 60

4.6 Customized Fenestrated Stent Grafts ............................................................................... 60

4.7 Multi-Branch Stent Grafts .................................................................................................. 61

4.8 Thoracic Endovascular Aneurysm Repair Unmet Needs ................................................... 62

4.9 Long-Term Clinical Data ................................................................................................... 63

5 Market Opportunity Analysis ..................................................................................................... 64

5.1 Emerging Markets ............................................................................................................. 64

5.2 Thoracic Aortic Disease Market ........................................................................................ 65

5.3 Addition of Physician Training Programs ........................................................................... 66

5.4 Disruptive Technologies .................................................................................................... 67

5.5 Minimally Invasive Trend ................................................................................................... 68

6 Market Drivers, Barriers, and Substitutes .................................................................................. 69

6.1 Driver: Rising Disease Prevalence .................................................................................... 69

6.1.1 Diabetes Mellitus ........................................................................................................... 69


Table of Contents


6.1.2 Hypertension ................................................................................................................. 69

6.1.3 Obesity .......................................................................................................................... 69

6.1.4 Tobacco Use ................................................................................................................. 70

6.2 Driver: Aging ..................................................................................................................... 70

6.3 Driver: Imaging.................................................................................................................. 71

6.4 Driver: Improved Clinical Outcomes with Endovascular Therapy....................................... 72

6.5 Driver: Time Savings ......................................................................................................... 72

6.6 Driver: Patient Demand and Awareness............................................................................ 73

6.7 Driver: Technological Developments ................................................................................. 74

6.7.1 Custom Branched and Fenestrated Stent Grafts ........................................................... 74

6.7.2 Low Profile Delivery Systems ........................................................................................ 74

6.8 Driver: Rising Competition and Innovation ........................................................................ 76

6.9 Barrier: Availability of Venture Capital ............................................................................... 76

6.10 Barrier: Burden of Rising Regulation ................................................................................. 77

6.11 Barrier: High Treatment Cost ............................................................................................ 78

6.12 Barrier: Proving Long-Term Efficacy ................................................................................. 79

6.13 Barrier: High Radiation Dosages with Excessive Imaging ................................................. 80

6.14 Surgical Limitations ........................................................................................................... 80

6.15 Barrier: Medical Device Excise Tax ................................................................................... 81

6.16 Substitute: Open Surgery .................................................................................................. 81

6.17 Substitute: Chimney Technique versus Fenestrated Grafts ............................................... 82

7 Competitive Assessment .......................................................................................................... 84

7.1 Overview ........................................................................................................................... 84


Table of Contents


7.2 Key Marketed Products ..................................................................................................... 84

7.2.1 Endovascular Aneurysm Repair and Thoracic Endovascular Aneurysm Repair Products

..................................................................................................................................... 84

8 Pipeline Assessment................................................................................................................. 95

8.1 Overview ........................................................................................................................... 95

8.2 Product Profiles ................................................................................................................. 95

8.2.1 Altura Medical Endograft ............................................................................................... 95

8.2.2 Cordis INCRAFT ........................................................................................................... 96

8.2.3 EndoSpan Horizon ........................................................................................................ 97

8.2.4 EndoSpan Nexus .......................................................................................................... 98

8.2.5 MicroPort Scientific Castor Branched Stent Graft System ............................................. 99

8.2.6 BiFlow Medical Novel Side-Branch Stent .................................................................... 100

8.2.7 Endoluminal Sciences Endograft Mechanism .............................................................. 101

8.2.8 Medtronic Valiant Mona LSA Stent Graft System ........................................................ 102

8.2.9 Endologix Ventana Fenestrated Stent Graft ................................................................ 102

9 Clinical Trials to Watch ........................................................................................................... 104

9.1 Overview ......................................................................................................................... 104

9.2 Altura Medical ................................................................................................................. 104

9.3 Cook Medical .................................................................................................................. 105

9.4 Gore Medical .................................................................................................................. 107

9.5 Terumo Corporation ........................................................................................................ 108

9.6 Endologix ........................................................................................................................ 109

9.7 TriVascular ...................................................................................................................... 110


Table of Contents


9.8 Bolton Medical ................................................................................................................ 111

9.9 Medtronic ........................................................................................................................ 112

9.10 Cordis Corporation .......................................................................................................... 114

10 Current and Future Players ..................................................................................................... 115

10.1 Overview ......................................................................................................................... 115

10.2 Trends in Corporate Strategy .......................................................................................... 115

10.3 Company Profiles ............................................................................................................ 116

10.3.1 Cook Medical .............................................................................................................. 116

10.3.2 Endologix .................................................................................................................... 119

10.3.3 Gore Medical ............................................................................................................... 122

10.3.4 Medtronic .................................................................................................................... 124

10.3.5 Terumo Corporation .................................................................................................... 127

10.3.6 Altura Medical ............................................................................................................. 129

10.3.7 Aptus Endosystems..................................................................................................... 130

10.3.8 Bolton Medical............................................................................................................. 132

10.3.9 Braile Biomédica ......................................................................................................... 134

10.3.10 B. Braun ...................................................................................................................... 137

10.3.11 Cardiatis ...................................................................................................................... 138

10.3.12 LeMaitre Vascular ....................................................................................................... 140

10.3.13 Lifetech Scientific ........................................................................................................ 142

10.3.14 Getinge Group............................................................................................................. 144

10.3.15 Grikin Advanced Materials........................................................................................... 147

10.3.16 Johnson & Johnson’s Cordis Corporation .................................................................... 148


Table of Contents


10.3.17 Jotec ........................................................................................................................... 150

10.3.18 Lombard Medical ......................................................................................................... 152

10.3.19 MicroPort Scientific Corporation .................................................................................. 153

10.3.20 Nano Endoluminal ....................................................................................................... 156

10.3.21 TriVascular .................................................................................................................. 158

10.3.22 Weike Medical Apparatus and Instrument ................................................................... 161

10.3.23 YTH Biological Material Scitech................................................................................... 161

11 Market Outlook ....................................................................................................................... 162

11.1 Company Market Share .................................................................................................. 162

11.2 By Market Segment......................................................................................................... 163

11.2.1 Overview ..................................................................................................................... 163

11.2.2 Endovascular Aneurysm Repair .................................................................................. 165

11.2.3 Thoracic Endovascular Aneurysm Repair .................................................................... 166

11.3 By Geography ................................................................................................................. 167

11.3.1 EU Overview ............................................................................................................... 167

11.3.2 EU ............................................................................................................................... 170

12 Appendix................................................................................................................................. 182

12.1 Bibliography .................................................................................................................... 182

12.2 Abbreviations .................................................................................................................. 196

12.3 Research Methodology ................................................................................................... 199

12.3.1 Overview ..................................................................................................................... 199

12.3.2 Coverage .................................................................................................................... 199

12.3.3 Secondary Research ................................................................................................... 199


Table of Contents


12.4 Physicians and Specialists Included in this Study ........................................................... 201

12.4.1 Christopher Abularrage, MD, FACS ............................................................................ 201

12.4.2 Gaspar Mestres Alomar, MD ....................................................................................... 201

12.4.3 Enio Buffolo, MD, PhD ................................................................................................ 201

12.4.4 Ludovic Canaud, MD, PhD .......................................................................................... 201

12.4.5 Holger Eggebrecht, MD ............................................................................................... 201

12.4.6 Daisuke Fukui, MD, PhD ............................................................................................. 201

12.4.7 Germano Melissano, MD ............................................................................................. 201

12.4.8 Dr. Raghuram Sekhar MS, FRCS (Edinburgh), FRCS (Glasgow) ................................ 201

12.4.9 Ferdinand Serracino-Inglott, MD, MSc, FRCSI, FRCS (Gen Surg), DIC ...................... 202

12.4.10 Jiang Xiong, MD, PhD ................................................................................................. 202

12.5 Primary Research ........................................................................................................... 203

12.5.1 Primary Research – Key Opinion Leader Interviews.................................................... 203

12.5.2 Primary Research – Physician and Industry Interviews ............................................... 203

12.5.3 Expert Panel Validation ............................................................................................... 204

12.6 Forecasting Methodology ................................................................................................ 205

12.7 About the Authors ........................................................................................................... 206

12.7.1 Analysts ...................................................................................................................... 206

12.7.2 Global Head of Healthcare .......................................................................................... 207

12.8 About MediPoint .............................................................................................................. 208

12.9 About GlobalData ............................................................................................................ 208

12.10 Disclaimer ....................................................................................................................... 208


Table of Contents


1.1 List of Tables

Table 1: Summary of Indications, Symptoms, and Treatments ....................................................................... 25

Table 2: Thoracic Aortic Aneurysm Types ...................................................................................................... 27

Table 3: Medications for Reducing Risk of Aneurysm Growth and Rupture .................................................... 30

Table 4: Advantages and Disadvantages of Open Repair versus Endovascular Repair .................................. 32

Table 5: Group Purchasing Organizations in the EU ...................................................................................... 40

Table 6: Regulatory Differences between the US and EU............................................................................... 42

Table 7: Direct and Indirect Costs of Open Surgery and Endovascular Repair ................................................ 52

Table 8: Comparison Costs and Other Variables for Treating AAA By Open Repair and Stent Grafts in 2012

($US) .......................................................................................................................................... 53

Table 9: Endoleak Types ............................................................................................................................... 54

Table 10: Zenith Family Marketed Products ................................................................................................... 86

Table 11: Zenith AAA SWOT ......................................................................................................................... 86

Table 12: Zenith TAA SWOT ......................................................................................................................... 87

Table 13: Endologix’s Marketed Products ...................................................................................................... 88

Table 14: AFX Endovascular SWOT .............................................................................................................. 88

Table 15: IntuiTrak Powerlink System SWOT ................................................................................................. 88

Table 16: Gore Medical’s Marketed Products ................................................................................................. 90

Table 17: Gore AAA Product SWOT .............................................................................................................. 90

Table 18: Gore TAA Product SWOT .............................................................................................................. 91

Table 19: Medtronic’s Marketed Products ...................................................................................................... 92

Table 20: Medtronic AAA Product SWOT ....................................................................................................... 93

Table 21: Medtronic TAA Product SWOT ....................................................................................................... 93

Table 22: Terumo Corporation Marketed Products ......................................................................................... 94


Table of Contents


able 23: Terumo Corporation AAA Product SWOT ......................................................................................... 94

Table 24: SWOT Analysis – Altura Medical Endograft .................................................................................... 96

Table 25: SWOT Analysis – Cordis INCRAFT ................................................................................................ 97

Table 26: SWOT Analysis – EndoSpan Horizon ............................................................................................. 98

Table 27: SWOT Analysis – EndoSpan Nexus ............................................................................................... 99

Table 28: SWOT Analysis – MicroPort Scientific Castor Branched Stent Graft System ................................. 100

Table 29: SWOT Analysis – BiFlow Medical Novel Side-Branch Stent .......................................................... 101

Table 30: SWOT Analysis – Endoluminal Sciences Endograft Mechanism ................................................... 101

Table 31: SWOT Analysis – Medtronic Valiant Mona LSA Stent Graft .......................................................... 102

Table 32: SWOT Analysis – Endologix Ventana Fenestrated Stent Graft...................................................... 103

Table 33: Major Clinical Trials of Altura Medical’s Aortic Stent Grafts ........................................................... 105

Table 34: Major Clinical Trials of Cook Medical’s Aortic Stent Grafts ............................................................ 106

Table 35: Major Clinical Trials of Gore Medical’s Aortic Stent Grafts............................................................. 107

Table 36: Major Clinical Trials of Terumo’s Aortic Stent Grafts ..................................................................... 108

Table 37: Major Clinical Trials of Endologix’s Aortic Stent Grafts .................................................................. 109

Table 38: Major Clinical Trials of TriVascular’s Aortic Stent Grafts ................................................................ 110

Table 39: Major Clinical Trials of Bolton Medical’s Aortic Stent Grafts .......................................................... 111

Table 40: Major Clinical Trials of Medtronic’s Aortic Stent Grafts .................................................................. 112

Table 41: Major Clinical Trials of Cordis’ Aortic Stent Grafts ......................................................................... 114

Table 42: Company Profile – Cook Medical.................................................................................................. 117

Table 43: Cook Medical Marketed Products ................................................................................................. 118

Table 44: SWOT Analysis – Cook Medical ................................................................................................... 119

Table 45: Company Profile – Endologix Inc. ................................................................................................. 120

Table 46: Endologix Marketed Products ....................................................................................................... 121


Table of Contents


Table 47: Endologix Pipeline Products ......................................................................................................... 121

Table 48: SWOT Analysis – Endologix Inc. .................................................................................................. 121

Table 49: Company Profile – Gore Medical .................................................................................................. 122

Table 50: Gore Medical Marketed Products ................................................................................................. 123

Table 51: SWOT Analysis – Gore Medical ................................................................................................... 124

Table 52: Company Profile – Medtronic ....................................................................................................... 125

Table 53: Medtronic Marketed Products ....................................................................................................... 126

Table 54: SWOT Analysis – Medtronic ......................................................................................................... 126

Table 55: Company Profile – Terumo Corporation........................................................................................ 127

Table 56:Terumo Corporation Marketed Products ........................................................................................ 128

Table 57: SWOT Analysis – Terumo Corporation ......................................................................................... 129

Table 58: Company Profile – Altura Medical Inc. .......................................................................................... 129

Table 59: Altura Medical Inc. Marketed Products ......................................................................................... 130

Table 60: SWOT Analysis – Altura Medical Inc. ........................................................................................... 130

Table 61: Company Profile – Aptus Endosystems, Inc. ................................................................................ 131

Table 62: Aptus Endosystems Inc. Marketed Products ................................................................................. 132

Table 63: SWOT Analysis – Aptus Endosystems Inc. ................................................................................... 132

Table 64: Company Profile – Bolton Medical ................................................................................................ 133

Table 65: Bolton Medical Marketed Products ............................................................................................... 134

Table 66: SWOT Analysis – Bolton Medical ................................................................................................. 134

Table 67: Company Profile – Braile Biomédica............................................................................................. 135

Table 68: Braile Biomédica Marketed Products ............................................................................................ 136

Table 69: SWOT Analysis – Braile Biomédica .............................................................................................. 136

Table 70: Company Profile – B. Braun ......................................................................................................... 137


Table of Contents


Table 71: B. Braun Marketed Products ........................................................................................................ 138

Table 72: SWOT Analysis – B. Braun .......................................................................................................... 138

Table 73: Company Profile – Cardiatis ......................................................................................................... 139

Table 74: Cardiatis Marketed Products ........................................................................................................ 139

Table 75: SWOT Analysis – Cardiatis .......................................................................................................... 140

Table 76: Company Profile – LeMaitre Vascular ........................................................................................... 141

Table 77: LeMaitre Vascular Medical Marketed Products ............................................................................. 141

Table 78: SWOT Analysis – LeMaitre Vascular ............................................................................................ 142

Table 79: Company Profile – Lifetech Scientific............................................................................................ 143

Table 80: Lifetech Scientific Marketed Products ........................................................................................... 143

Table 81: SWOT Analysis – Lifetech Scientific ............................................................................................. 144

Table 82: Company Profile – Getinge Group ................................................................................................ 145

Table 83: Getinge Group Marketed Products ............................................................................................... 146

Table 84: SWOT Analysis – Getinge Group ................................................................................................. 146

Table 85: Company Profile – Grikin Advanced Materials .............................................................................. 147

Table 86: Grikin Advanced Materials Marketed Products ............................................................................. 147

Table 87: SWOT Analysis – Grikin Advanced Materials ............................................................................... 148

Table 88: Company Profile – Johnson & Johnson Cordis Corporation .......................................................... 148

Table 89: Cordis Corporation’s Pipeline Product .......................................................................................... 149

Table 90: SWOT Analysis – Cordis Corporation ........................................................................................... 149

Table 91: Company Profile – Jotec .............................................................................................................. 150

Table 92: Jotec’s Marketed Products ........................................................................................................... 151

Table 93: SWOT Analysis – Jotec ................................................................................................................ 151

Table 94: Company Profile – Lombard Medical ............................................................................................ 152


Table of Contents


Table 95: Lombard Medical Marketed Products ........................................................................................... 153

Table 96: SWOT Analysis – Lombard Medical ............................................................................................. 153

Table 97: Company Profile – Microport Scientific Corporation ...................................................................... 154

Table 98: MicroPort Scientific Marketed Products ........................................................................................ 155

Table 99: SWOT Analysis – MicroPort Scientific .......................................................................................... 156

Table 100: Company Profile – Nano Endoluminal ........................................................................................ 157

Table 101: Nano Endoluminal Medical Marketed Products ........................................................................... 157

Table 102: SWOT Analysis – Nano Endoluminal .......................................................................................... 158

Table 103: Company Profile – TriVascular ................................................................................................... 159

Table 104: TriVascular Marketed Products................................................................................................... 160

Table 105: SWOT Analysis – TriVascular .................................................................................................... 160

Table 106: 5EU Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011–2020 ...................................... 164

Table 107: 5EU Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011–2020 ............................................... 165

Table 108: 5EU Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011–2020 ............................................. 166

Table 109: Aortic Stent Grafts Sales ($m) for the 5EU, 2011–2020 .............................................................. 167

Table 110: Aortic Stent Grafts Sales ($m) Forecast for the 5EU, 2011–2020 ................................................ 170

Table 111: Aortic Stent Grafts Sales ($m) Forecast for France, 2011–2020.................................................. 172

Table 112: Aortic Stent Grafts Sales ($m) Forecast for Germany, 2011–2020 .............................................. 174

Table 113: Aortic Stent Grafts Sales ($m) Forecast for Italy, 2011–2020 ...................................................... 177

Table 114: Aortic Stent Grafts ($m) Forecast for Spain, 2011–2020 ............................................................. 179

Table 115: Aortic Stent Grafts Sales ($m) Forecast for the UK, 2011–2020 .................................................. 181


Table of Contents


1.2 List of Figures

Figure 1: Treatment Methodology Markov Model ........................................................................................... 29

Figure 2: Aortic Stent Graft Product Image ..................................................................................................... 32

Figure 3: EU Abdominal Aortic Stent Grafts Procedure Volume, 2011–2020 .................................................. 34

Figure 4: EU Thoracic Aortic Stent Grafts Procedure Volume, 2011–2020 ..................................................... 35

Figure 5: EU Market Share for EVAR, 2013 ................................................................................................. 162

Figure 6: EU Market Share for TEVAR, 2013 ............................................................................................... 163

Figure 7: 5EU Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011–2020 ......................................... 164

Figure 8: 5EU Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011–2020 .................................................. 165

Figure 9: 5EU Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011–2020 ................................................ 166

Figure 10: Aortic Stent Grafts Sales ($m) for 5EU, 2011–2020 ..................................................................... 168

Figure 11: Aortic Stent Grafts by Major Market, 2013 and 2020 .................................................................... 169

Figure 12: 5EU Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 ...................................................... 171

Figure 13: France Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 .................................................. 173

Figure 14: Germany Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 ............................................... 175

Figure 15: Italy Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 ....................................................... 177

Figure 16: Spain Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 .................................................... 179

Figure 17: UK Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 ........................................................ 181

Figure 18: Aortic Stent Graft Primary Research, Supply and Demand-Side Interviews.................................. 204



Introduction

2 Introduction

Aortic stent grafts are most commonly used to reinforce a weak spot in an artery, which is known

as an aneurysm. The stent grafts are designed to seal tightly with the patient’s native artery above

and below the aneurysm, and are used to treat abdominal aortic aneurysms (AAAs) as well as

thoracic aortic aneurysms (TAAs). Aortic aneurysms, as opposed to aneurysms found elsewhere in

the body, are potentially very serious, as a burst aorta results in massive internal bleeding that can

be fatal unless treated rapidly by an experienced emergency medical team. Since their introduction

in patients in 1991, aortic stent graft devices have gained wide acceptance and availability, with

their adoption fueled in great part by advances in stent-graft design and by a variety of devices for

various anatomic features. Over time, these devices have gained traction for use in patients with

ruptured aneurysms because they are minimally invasive and have shorter recovery times.

Based on GlobalData’s key opinion leader (KOL) research, in the more mature Western markets,

about 80% of surgical treatments for aneurysms are treated through endovascular therapy. The

remaining market is treated by open surgical options. This surgical rate is reduced further in the

emerging nations, due to the high product cost. While endovascular therapy has its clear benefits,

there are strong arguments still being made both clinically, and from a cost perspective, to continue

doing open surgery. Overall, this minimally invasive endovascular technique saves hospitalization

costs in the short run while it continues to bring in revenue for hospitals and practices, as several

more of these cases can be scheduled in a day, with shorter surgical times.

From a clinical standpoint, there are a multitude of clinical trials in progress as the stent grafts and

their delivery systems are trending towards lower and lower profile systems, thereby allowing the

products to be used on a wider patient population that previously, was treatable only through open

techniques. Overall, GlobalData expects the procedural data to continue to grow across the

European major markets (5EU) (France, Germany, Italy, Spain and UK,), with the greatest

opportunity being in the emerging nations.

This report focuses on the aortic stent graft implant market for abdominal and TAAs. The

abdominal aortic market comprises about 80–90% of the market, with the niche market being the

thoracic one. The thoracic aneurysm repair market is still a young market where there is a strong

pipeline of products from both the large manufacturers and small emerging players. For most

manufacturers, following the successful launch of an AAA product, the thoracic stent graft segment

presents the opportunity with the most unmet needs for pursuit.



Introduction

The 5EU are covered and forecast in this report, which provides the unmet needs, future adoption,

and Compound Annual Growth Rates (CAGRs) in both the abdominal stent graft and thoracic stent

graft markets. GlobalData’s analysis demonstrates this market to be a young and growing market,

subject to rapid technological development and with much room for product adoption.

2.1 Catalyst

Increasing the applicability of aortic stent grafts to patients with difficult anatomic features will

likewise require improvements as well as innovation in device design. Currently, the three most

common anatomic reasons for exclusion from the endovascular repair of AAAs are inappropriate

aortic (proximal) neck access, iliac artery aneurysms, and inadequate iliac access. Researchers

have noted that the next frontier for aortic stent grafts will be the continued adoption and

development of endografts that are capable of treating various types of aortic aneurysms for a

number of different patient anatomies. Further, in order to avoid follow-up on patients with

implanted devices, future aortic stent graft products will have increased durability, refined designs

to allow for treatment in the most difficult anatomies, and advanced abilities to treat aneurysms

involving the renal and visceral segments of the aorta.

There are significant opportunities remaining for companies that can develop slimmer devices with

reduced sheath diameter, improve the fixation of grafts, or add additional features including

branches or fenestrated necks. Currently, some of the most frequently encountered barriers for

aortic stent graft use consist of an inadequate or inappropriate proximal neck anatomy and an

inadequate caliber of iliofemoral access vessels. As such, the ability of devices to accommodate

patients with difficult necks or treacherous access vessels is important. That said, novel bifurcated

endografts along with the development of widely available branched and fenestrated grafts are

expected to address these barriers, thereby improving upon the already remarkable clinical

success of this procedure. This report looks at the current aortic stent grafts market for

cardiovascular disease and evaluates the adoption and opportunities for this technology in the

5EU. In the 5EU region, this market is expected to rise from $288 million in 2014 to $445 million in

2020, at a CAGR of 6.4%.

Currently, some of the most frequently encountered barriers for aortic stent graft use consist of an inadequate or inappropriate proximal neck anatomy and an inadequate caliber of iliofemoral access vessels.



Introduction

2.2 Related Reports

GlobalData (2012). Bioabsorbable Stents – Global Market Analysis and Forecasts, December

2012, GDME0164MAR

GlobalData (2012). Peripheral Vascular Stents – Global Market Analysis and Forecasts, April

2012, GDME0168MAR

GlobalData (2013). Drug Eluting Balloons – Global Market Analysis and Forecasts, September

2013, GDME0179MAR

GlobalData (2014). Neurovascular Interventions – Global Market Analysis and Forecasts April

2014, GDME0194MAR

2.3 Upcoming Related Reports

GlobalData (2014). Coronary Stents – Global Market Analysis and Forecast, to be published


Appendix


12.8 About MediPoint

MediPoint is the flagship product for GlobalData’s Medical team. Each MediPoint report is built

from the ground up by our team of healthcare analysts in the US and UK. Each report includes

input from experienced physicians and leading Key Opinion Leaders (KOLs). Running throughout

each report in the series are, “What Do Physicians Think” quotes, which provide a unique insight

into how healthcare professionals are reacting to events within the industry, and what their

responses could mean for industry strategists.

12.9 About GlobalData

GlobalData is a leading global provider of business intelligence in the healthcare industry.

GlobalData provides its clients with up-to-date information and analysis on the latest developments

in drug research, disease analysis, and clinical research and development. Our integrated business

intelligence solutions include a range of interactive online databases, analytical tools, reports, and

forecasts. Our analysis is supported by a 24/7 client support and analyst team.

GlobalData has offices in New York, San Francisco, Boston, London, India, Korea, Japan,

Singapore, and Australia.

12.10 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any

form by any means, electronic, mechanical, photocopying, recording, or otherwise without the prior

permission of the publisher, GlobalData.

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