realizing the new era thoratec ® product development initiatives
TRANSCRIPT
Realizing the New Era
Thoratec® Product Development Initiatives
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Thoratec Corporation
Lead the use of Mechanical Circulatory Support (MCS) to
dramatically improve outcomes for patients with advanced stage
heart failure and other cardiovascular diseases
More than 18,000 patients implanted worldwide
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Product Development Strategy Overview
HeartMate II Evolution Next-Generation PumpsCross-Platform
Breakthrough Technologies
• Maintain HeartMate II as the best-in-class LVAD
– GoGear Peripherals
– Driveline durability
– Sealed grafts
– G2 System Controller
– LV attachment tools
– Mobile Power Unit
• Introduce a range of pumps to significantly improve upon clinical capabilities of current commercial and clinical devices and expand the addressable patient populations
– HeartMate III
– HeartMate X
– PHP
• Introduce technologies which substantially enhance MCS therapy for both patients and clinicians, supporting both HeartMate II leadership and future pump platforms
– FILVAS
– Automated anastomosis
– Infection reduction
– Wireless architecture
– Remote monitoring
Improved Outcomes, Enhanced Quality of Life, Less Invasive Procedure, Real-Time Information, Reduced Cost of Care, Expanded Patient Populations
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Agenda
Next-Generation Pumps
Cross-Platform Breakthrough Technologies
HeartMate II® Evolution
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HeartMate II® Product Evolution – Projected Timelines
Sealed Grafts
G2Controller
Surgical Tools – LV Attachment
2011 20122009
GoGearPeripherals
Driveline Durability
2010
Worldwide Commercial
Launch
Mobile Power Unit
InitiatingDevelopment
MPU
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HeartMate GoGear System Components
14 volt Batteries and Clips (Li-Ion)
Power Module
Battery Charger HeartMate GoGear
System Components(Launched 2009)
Redesigned system components support a patient’s recently restored active lifestyle, providing mobility and flexibility in a safe and secure manner
HeartMate GoGear System Components
(Launched 2009)
Redesigned system components support a patient’s recently restored active lifestyle, providing mobility and flexibility in a safe and secure manner
SmartController
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Sealed Inflow Conduit and Outflow Graft
Sealed Outflow Graft
Sealed Inflow Conduit
Sealed Inflow and Outflow(Outflow in limited evaluation)(Inflow in limited evaluation)
• Eliminates pre-clotting and associated preparation time.
• If needed, the Outflow Graft bend relief can be removed after initial attachment.
• Maintains flexible Inflow Conduit design:
– accommodates anatomic changes as patient recovers
– allows range of angles between pump and inflow conduit
– articulation allows adaptation and variety of VAD placement options
Sealed Inflow and Outflow(Outflow in limited evaluation)(Inflow in limited evaluation)
• Eliminates pre-clotting and associated preparation time.
• If needed, the Outflow Graft bend relief can be removed after initial attachment.
• Maintains flexible Inflow Conduit design:
– accommodates anatomic changes as patient recovers
– allows range of angles between pump and inflow conduit
– articulation allows adaptation and variety of VAD placement options
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HeartMate II G2 System Controller
Advanced System Controller(Finalizing Design)
Significant quality-of-life improvement for patients
− Smaller and lighter than currently available controllers
− Easier cable management− Can be carried in patient’s pocket − LCD and enhanced user interface
Enhanced patient safety− Backup battery built into controller
Advanced System Controller(Finalizing Design)
Significant quality-of-life improvement for patients
− Smaller and lighter than currently available controllers
− Easier cable management− Can be carried in patient’s pocket − LCD and enhanced user interface
Enhanced patient safety− Backup battery built into controller
G1 Controller G2 Controller
Weight (g) ~635 ~360Dimensions (cm) 19.0 x 9.7 x 3.6 13.0 x 7.7 x 3.0Volume (cm3) ~660 ~300
Backup Power No Yes
LCD Screen No Yes
Front
Back
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Surgical Implant Tools – Left Ventricle Attachment
Left Ventricle Attachment(Finalizing Design)
• Coring tool designed to create and extract a clean, circular core
− Ease of cannula placement− Maintains visibility into left
ventricle
• Reduced bypass time− Sewing ring installed before
coring
• Reduced surgical time / enhanced ease of use (quick clamp)
Left Ventricle Attachment(Finalizing Design)
• Coring tool designed to create and extract a clean, circular core
− Ease of cannula placement− Maintains visibility into left
ventricle
• Reduced bypass time− Sewing ring installed before
coring
• Reduced surgical time / enhanced ease of use (quick clamp)
Sewing Ring and Quick Clamp
Coring Tool
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21’ power lead(fully extended)
HeartMate Mobile Power Unit
Powered Portability(Initiating Development)
Highly portable tethered power solution with built-in cable management− Small size, low weight− Increased ability to use tethered power with discretion
Powered Portability(Initiating Development)
Highly portable tethered power solution with built-in cable management− Small size, low weight− Increased ability to use tethered power with discretion
Indicators provide reassurance of device function
A/C Power
MPU body incorporates cable management capability
MPU
G2 System Controller
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Agenda
Next-Generation Pumps
Cross-Platform Breakthrough Technologies
HeartMate II® Evolution
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Next-Generation Pump – Projected Timelines
2011 2012 2013 2014
First-In-ManHeartMate III
PHP
HeartMate X
Also in Development
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HeartMate IIIUltra-Compact, Fully Mag-Lev VAD
(Finalizing Design)
• Full support (10L / min) in ultra-compact size− Intrathoracic placement; centrifugal flow
• Incorporates critical HeartMate family design elements (e.g. large gaps, textured surfaces)
– Reduced adverse event profile– Potential for reduced or no
anticoagulation
• Full magnetic levitation optimized for efficiency− Operate at lower power consumption,
allowing miniaturization of external components
• Capable of producing an artificial pulse – Physiologic blood flow with potential to
help address late bleeding
• Leverage all product development initiatives from HeartMate II
Ultra-Compact, Fully Mag-Lev VAD(Finalizing Design)
• Full support (10L / min) in ultra-compact size− Intrathoracic placement; centrifugal flow
• Incorporates critical HeartMate family design elements (e.g. large gaps, textured surfaces)
– Reduced adverse event profile– Potential for reduced or no
anticoagulation
• Full magnetic levitation optimized for efficiency− Operate at lower power consumption,
allowing miniaturization of external components
• Capable of producing an artificial pulse – Physiologic blood flow with potential to
help address late bleeding
• Leverage all product development initiatives from HeartMate II
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Percutaneous Heart Pump (PHP)
Catheter-based axial flow pump
(Finalizing Design)
• Designed to deliver over 4L of flow under normal physiologic conditions
• Percutaneous placement through 11F sheath
• Collapsible elastomeric impeller and nitinol cannula; expands to ~24F
Catheter-based axial flow pump
(Finalizing Design)
• Designed to deliver over 4L of flow under normal physiologic conditions
• Percutaneous placement through 11F sheath
• Collapsible elastomeric impeller and nitinol cannula; expands to ~24F
• Unstable AMI
• High-risk PCI
• Acutely decompensated heart failure
• Potentially other patient populations
Targeted Applications
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HeartMate X
Dramatically Downsized Chronic Device(Technology Development)
• Versatile platform, capable of providing partial and full support (1-8 L/min)
• Leverages core HeartMate II technology
• Dramatic size reduction− Rapid, less invasive implant− Versatile cannulation options
• Meets needs of expanded patient pool− Earlier-stage patients− RVAD / BiVAD population
• Low power consumption− Potential for smaller external batteries
and components
Dramatically Downsized Chronic Device(Technology Development)
• Versatile platform, capable of providing partial and full support (1-8 L/min)
• Leverages core HeartMate II technology
• Dramatic size reduction− Rapid, less invasive implant− Versatile cannulation options
• Meets needs of expanded patient pool− Earlier-stage patients− RVAD / BiVAD population
• Low power consumption− Potential for smaller external batteries
and components
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Agenda
Next-Generation Pumps
Cross-Platform Breakthrough Technologies
HeartMate II® Evolution
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Cross-Platform Technologies
2011 2012 2013 2014
Fully Implantable System
First-In-Man
AutomatedAnastomosis
Also in Development
Infection Reduction
RemoteMonitoring
Wireless Architecture
Patient Information
via web page
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Fully-Implantable LVAS (FILVAS)
Fully Implantable System(Finalizing Design)
• No percutaneous lead – improved infection and system durability profile
• Quality of life− No daily dressings− Ability to swim and shower− Less limitations on movement
• Advanced battery technology− Custom cell technology tailored for
implantable LVAD application− Targeting “untethered” run times of ~3
hours initially and ~2 hours at 3-year mark
• Reduced size Implanted components with highly reliable electronics
Fully Implantable System(Finalizing Design)
• No percutaneous lead – improved infection and system durability profile
• Quality of life− No daily dressings− Ability to swim and shower− Less limitations on movement
• Advanced battery technology− Custom cell technology tailored for
implantable LVAD application− Targeting “untethered” run times of ~3
hours initially and ~2 hours at 3-year mark
• Reduced size Implanted components with highly reliable electronics
Implanted Controller
Implanted Battery
Energy Transfer Coil Configured with
choice of pump
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Infection Reduction Technology
Project Objectives
• Develop stabilization and exit site improvement technologies to significantly reduce percutaneous lead (driveline) infection
• Pursuing device-based internal mechanical stability anchoring technologies
– Focus on trauma-induced late-onset infection
• Advanced exit site material morphology and chemistry for improved tissue / percutaneous lead interface
Project Objectives
• Develop stabilization and exit site improvement technologies to significantly reduce percutaneous lead (driveline) infection
• Pursuing device-based internal mechanical stability anchoring technologies
– Focus on trauma-induced late-onset infection
• Advanced exit site material morphology and chemistry for improved tissue / percutaneous lead interface
Maximum Force at Cutaneous Tissue Separation
0
5
10
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Control Test
Fo
rce
(lb
)
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Automated Anastomosis
Project Objectives
• “One shot" deployment tool that mechanically affixes an apical attachment device to the exterior of the heart’s left ventricle.
• Automate the procedure and eliminate routine sewing of today's cuff
• Reproducibility - a mechanized tool/procedure eliminates variability
• Shorten procedural time - reduce operative time by 15-25 minutes
Project Objectives
• “One shot" deployment tool that mechanically affixes an apical attachment device to the exterior of the heart’s left ventricle.
• Automate the procedure and eliminate routine sewing of today's cuff
• Reproducibility - a mechanized tool/procedure eliminates variability
• Shorten procedural time - reduce operative time by 15-25 minutes
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HeartMate Wireless Architecture
Current Future
**Both SM and PM are required for in-clinic programming and monitoring
**
HeartTouchTablet Computer
WirelessSystem Controller
Project Objectives
• In-clinic LVAS programming and monitoring platform aimed at reducing cost while improving practice efficiency and usability.
• Integrate wireless hardware into G2 System Controller
• Utilize current System Monitor software & improve− Graphic interface (organization, layout)− Incorporate Trending (PI, Flow, Speed, Power)
• Combines TLC II and HeartMate monitoring and programming platforms
Project Objectives
• In-clinic LVAS programming and monitoring platform aimed at reducing cost while improving practice efficiency and usability.
• Integrate wireless hardware into G2 System Controller
• Utilize current System Monitor software & improve− Graphic interface (organization, layout)− Incorporate Trending (PI, Flow, Speed, Power)
• Combines TLC II and HeartMate monitoring and programming platforms
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Remote Monitoring
WirelessSystem Controller
LVAD Patient
HomeHome or Office
Alert Notifications
Patient Information
via web page
Internet
Internet
Data
Project Objectives
• Offer a Remote Patient Monitoring solution for ongoing CCS devices that provides clinically relevant, accurate and trended parameter information
• Clinician is able to obtain LVAS data from a wireless G2 controller through a in-home router.
• Clinician can remotely observe and review data on all of their patients
• Alert notification when an patient parameter exceeds a clinician set boundary condition
Project Objectives
• Offer a Remote Patient Monitoring solution for ongoing CCS devices that provides clinically relevant, accurate and trended parameter information
• Clinician is able to obtain LVAS data from a wireless G2 controller through a in-home router.
• Clinician can remotely observe and review data on all of their patients
• Alert notification when an patient parameter exceeds a clinician set boundary condition
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PVAD & IVAD Product Development
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TLC-II Plus
TLC-II Plus Driver(will launch in early 2011)
• Expanded RVAD capabilities allow for improved management of right-heart dysfunction• Support for stable/unstable• LVAD, RVAD, BiVAD
• Improved reliability will allow 8,000 hours (~11 months) of maintenance-free operation
• Compact design allows home discharge: BiVAD patients the freedom to enjoy a more normal lifestyle
TLC-II Plus Driver(will launch in early 2011)
• Expanded RVAD capabilities allow for improved management of right-heart dysfunction• Support for stable/unstable• LVAD, RVAD, BiVAD
• Improved reliability will allow 8,000 hours (~11 months) of maintenance-free operation
• Compact design allows home discharge: BiVAD patients the freedom to enjoy a more normal lifestyle
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HeartTouch® Mobile
HeartTouch Mobile(will launch early 2011)
• Lightweight and portable touchscreen computer
• Allows wireless control, monitoring, and downloading of data from the TLC-II
• Establishes a new computer platform with the potential to support HeartMate devices in the future
HeartTouch Mobile(will launch early 2011)
• Lightweight and portable touchscreen computer
• Allows wireless control, monitoring, and downloading of data from the TLC-II
• Establishes a new computer platform with the potential to support HeartMate devices in the future
MERCI DE VOTRE
ATTENTION
20ième congrès AFICCT
Hommage à celles qui ont travaillé au sein du Bureau au
fil du temps