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Realizing the New Era Thoratec ® Product Development Initiatives.

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Presentation on theme: "Realizing the New Era Thoratec ® Product Development Initiatives."— Presentation transcript:

1 Realizing the New Era Thoratec ® Product Development Initiatives

2 2 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

3 3 Product Development Strategy Overview HeartMate II Evolution Next-Generation Pumps Cross-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

4 4 Agenda Next-Generation Pumps Cross-Platform Breakthrough Technologies HeartMate II ® Evolution

5 5 HeartMate II ® Product Evolution – Projected Timelines Sealed Grafts G2 Controller Surgical Tools – LV Attachment GoGear Peripherals Driveline Durability 2010 Worldwide Commercial Launch Mobile Power Unit Initiating Development

6 6 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 patients 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 patients recently restored active lifestyle, providing mobility and flexibility in a safe and secure manner Smart Controller

7 7 Pump-end Bend Relief Enhancement (Launched 2010) Reduces the occurrence of Driveline pump-end bend relief fractures. Design: Focus: Driveline Durability

8 8 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

9 9 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 patients 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 patients pocket LCD and enhanced user interface Enhanced patient safety Backup battery built into controller G1 ControllerG2 Controller Weight (g)~635~360 Dimensions (cm)19.0 x 9.7 x x 7.7 x 3.0 Volume (cm 3 )~660~300 Backup PowerNoYes LCD ScreenNoYes Front Back

10 10 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

11 11 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

12 12 Agenda Next-Generation Pumps Cross-Platform Breakthrough Technologies HeartMate II ® Evolution

13 13 Next-Generation Pump – Projected Timelines First-In-Man HeartMate III PHP HeartMate X Also in Development

14 14 HeartMate III 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 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

15 15 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

16 16 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

17 17 Agenda Next-Generation Pumps Cross-Platform Breakthrough Technologies HeartMate II ® Evolution

18 18 Cross-Platform Technologies Fully Implantable System First-In-Man Automated Anastomosis Also in Development Infection Reduction Remote Monitoring Wireless Architecture

19 19 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

20 20 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

21 21 Automated Anastomosis Project Objectives One shot" deployment tool that mechanically affixes an apical attachment device to the exterior of the hearts 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 minutes Project Objectives One shot" deployment tool that mechanically affixes an apical attachment device to the exterior of the hearts 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 minutes

22 22 HeartMate Wireless Architecture Current Future ** Both SM and PM are required for in-clinic programming and monitoring ** HeartTouch Tablet Computer Wireless System 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

23 23 Remote Monitoring Wireless System Controller LVAD Patient Home Home 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

24 Realizing the New Era Thoratec ® Product Development Initiatives

25 25 Appendix 1.PVAD and IVAD Product Development 2.Driveline Product Development 3.HeartMate II Technology Review

26 26 PVAD & IVAD Product Development

27 27 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

28 28 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

29 MERCI DE VOTRE ATTENTION

30 30 Driveline Product Development

31 31 Driveline Clinical Failure Modes Summary Points of wear and fatigue HM II Percutaneous Lead Damage Revision A-C (January 2004 ~1,010 impl.) Revision E+ (June 2007 >5584 impl.) Bend Relief Separation / Controller-end Connector 226 (22.4%)118 (2.1%) Jacket Cuts / Tears 51 (5.0%)76 (1.4%) Tapered end of Controller Bend Relief 45 (4.5%)8 (0.1%) Pump Housing 29 (0.4%) General Trauma ~4 Wire Repair / replacements performed in the field 24 (2.4%)11 (0.2%) Through 12/31/2010: 6,594 implants

32 32 Perc Lead Wire Repair Kit An alternate solution to pump replacement (Launched April, 2010) An externalized section of the driveline can be replaced by trained Thoratec Technical Services personnel Kit includes: Perc Lead Diagnostics One replacement lead Installation by two Thor Tech Services personnel Patient instructions

33 33 HeartMate III Driveline and Tunneling System Capable of withstanding the rigors of daily life (Finalizing design) Enhanced driveline durability Modular lead section that can be replaced in case of damage or wear. Enhanced driveline tunneling system accommodates a wide range of patient sizes and variations in patient anatomy Capable of withstanding the rigors of daily life (Finalizing design) Enhanced driveline durability Modular lead section that can be replaced in case of damage or wear. Enhanced driveline tunneling system accommodates a wide range of patient sizes and variations in patient anatomy

34 34 HeartMate II Technology Review

35 35 HeartMate II Update Best-in-Class LVAD: greater than 6,000 implants in real-world patient population at 254 centers as of year-end 2010 Greater than 3,000 ongoing patients; durability profile extremely impressive Greater than 700 patients supported 2 years or longer – Over 60 patients for 4+ years – Longest patient: 6+ years

36 36 HeartMate II – Design Features and Benefits Design Overview Design Benefits Optimized blood flow Low thrombosis risk Low anti-coagulation needs Durability Textured surfaces Highly durable ruby bearings– negligible wear Rotor–single moving part Large gaps– optimal flow dynamics Flexible inflow conduit

37 37 Optimized Flow Path and Impressive Durability Profile Bearing Technology Flow Path Simplicity of design – single moving part Inflow and outflow stators straighten the blood flow as it enters and exits the pump Large gaps minimize potential for stasis and thrombus formation Rotor spins on ruby bearings Blood-immersed – Designed to prevent heat build-up that could damage blood and potentially cause thrombus formation No reported failures in >6k implants Analysis of explanted pumps indicates an average expected bearing life of 60 years * 4.4 year explant Large Gaps * Source: Reichenbach et al, Neglible Bearing Wear in Explanted HeartMate II LVADs Following Clinical Support for up to Four Years, International Society for Rotary Blood Pumps (ISRBP), October 2010.

38 38 Textured Surfaces Technology Overview Hallmark of HeartMate product family; technology refined over last two decades Textured titanium surfaces on both the inflow and outflow cannula Encourages the formation of a dense, adherent neointimal tissue layer * – Tissue layer mimics that found in native arteries – Reduces risk of thrombus formation generated by blood flow over foreign surfaces Textured Surfaces Application in HeartMate II Platform technology applied across HeartMate family of products * Source: Zapanta et al, ASAIO, 2006, 52:17-23

39 39 Flexible Inflow Conduit Technology OverviewFlexible Inflow Conduit – Design Flex section consists of: – Knitted polyester graft reinforced with a titanium ring and a silastic rubber sleeve Flexibility allows for relative movement between the native left ventricle and the LVAD – Accommodates reverse remodeling of heart over time while maintaining cannula position inside left ventricle Prevents misalignment against ventricular wall Helps avoid suckdown events Suction detection algorithm – Detects suction events and automatically adjusts pump speed – Helps prevent adverse events such as ventricular arrhythmias, flow interruption, or damage to the left ventricle Inflow Conduit Flex Section

40 Hommage à celles qui ont travaillé au sein du Bureau au fil du temps


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