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Realizing the New Era Thoratec ® Product Development Initiatives

Realizing the New Era Thoratec ® Product Development Initiatives. 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.

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Realizing the New Era Thoratec ® Product Development Initiatives

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  1. Realizing the New Era Thoratec® Product Development Initiatives

  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. Product Development Strategy Overview Cross-Platform Breakthrough Technologies Next-Generation Pumps HeartMate II Evolution • 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 • 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 • Maintain HeartMate II as the best-in-class LVAD • GoGear Peripherals • Driveline durability • Sealed grafts • G2 System Controller • LV attachment tools • Mobile Power Unit Improved Outcomes, Enhanced Quality of Life, Less Invasive Procedure, Real-Time Information, Reduced Cost of Care, Expanded Patient Populations

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

  5. HeartMate II® Product Evolution – Projected Timelines 2012 2011 2010 2009 GoGear Peripherals Worldwide Commercial Launch Driveline Durability Sealed Grafts G2Controller Surgical Tools – LV Attachment Mobile Power Unit Initiating Development

  6. HeartMate GoGear System Components 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 14 volt Batteries and Clips (Li-Ion) Power Module Smart Controller

  7. Sealed Inflow Conduit and Outflow Graft • 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 Outflow Graft Sealed Inflow Conduit

  8. 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 Front Back

  9. Surgical Implant Tools – Left Ventricle Attachment Sewing Ring and 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) Coring Tool

  10. HeartMate Mobile Power Unit Indicators provide reassurance of device function MPU A/C Power 21’ power lead (fully extended) MPU body incorporates cable management capability G2 System Controller • 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

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

  12. Next-Generation Pump – Projected Timelines 2014 2013 2012 2011 HeartMate III First-In-Man PHP HeartMate X Also in Development

  13. 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

  14. 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 Targeted Applications • Unstable AMI • High-risk PCI • Acutely decompensated heart failure • Potentially other patient populations

  15. 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

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

  17. Cross-Platform Technologies 2014 2013 2012 2011 Fully Implantable System First-In-Man Automated Anastomosis Remote Monitoring Wireless Architecture Infection Reduction Also in Development

  18. 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 Energy Transfer Coil Configured with choice of pump Implanted Controller Implanted Battery

  19. 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

  20. AutomatedAnastomosis • 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

  21. 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

  22. Remote Monitoring Home or Office Home Internet Data LVAD Patient Patient Information via web page Wireless System Controller Alert Notifications • 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

  23. PVAD & IVAD Product Development

  24. 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

  25. 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

  26. MERCI DE VOTRE ATTENTION

  27. 20ième congrès AFICCT Hommage à celles qui ont travaillé au sein du Bureau au fil du temps

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