11 B Assistance ventriculaire Les produits en développement Pr Camille Dambrin Service de chirurgie cardio-vasculaire, CHU Toulouse-Rangueil
2 B Lead the use of Mechanical Circulatory Support (MCS) to dramatically improve outcomes for patients with advanced heart failure Continual improvement of clinical outcomes Transparent, rigorous clinical research Increasing awareness and education Technology innovation leadership Market leadership across the spectrum of MCS Vision for and commitment to the future of MCS Our Values / Our Commitments Thoratec Corporation
3 3 Assistance à court terme Acute/Internediate Support
4 B CentriMag ® Acute/Internediate Support
5 B CentriMag Recent Additions 2nd Gen Console Surgical Cannulae System Cart Transporter Available Acute/Internediate Support
6 B HeartMate PHP® *In development. Not approved for clinical use Acute/Internediate Support
7 B Cardiac Catheter Pump Low-profile percutaneous device delivered through 13F sheath Expands to 24F across aortic valve Designed to deliver over 4 lpm for up to 10 days Cardiac Catheter Pump Low-profile percutaneous device delivered through 13F sheath Expands to 24F across aortic valve Designed to deliver over 4 lpm for up to 10 days HeartMate PHP* *In development. Not approved for clinical use Target Applications Acute MI Cardiogenic Shock High-risk PCI Acutely decompensated heart failure Acute/Internediate Support
8 8 Assistance à long terme Chronic Support
9 B Chronic Support
10 B Power Unit Evolution Chronic Support
11 Mobile Power Unit (MPU)* Enhanced Functionality Easier patient management (1,3 kg) Improved mobility and cable management Low maintenance (only AAA batteries) Long cable (6,4m) Safety Design Echoes System Controller alarms (even if power is lost) Internal Diagnostics Improved durability Twist resistant cables Commercial use targeted for june 2015 Designing for Portable and Patient-Friendly VAD Power Expected Benefits Program Status Chronic Support
12 B HeartMate II System Chronic Support
13 HeartMate ® III with Full MagLev™ Designed with a Healthy Respect for the Blood *Caution: Investigational device. Limited by Federal US law to investigational use Chronic Support
14 B What is Full MagLev? Uses magnets to support all six degrees of freedom of the rotor, such that the rotor remains essentially fixed except for rotation. (Doesn’t use physical or hydrodynamic/blood bearings) Chronic Support
15 B HeartMate III*: Full MagLev™ Technology Key Design Features: Large and Consistent Gaps (Designed to minimize Shear Stress and Blood Component Activation) – HeartMate III secondary flow paths are ~0.5 mm along the side, and ~1.0 mm pump above and below the rotor. – Conversely, hydrodynamic bearings are typically operated with much smaller gaps, 0.05 of a millimeter or so. – HeartMate III pump surfaces are flat and flow is undisturbed; wedging surfaces and other features required for hydrodynamic bearings are not required. ~ 0.5 mm along the side ~ 1.0 mm top and bottom Chronic Support
16 B How much difference is there? From a Red Blood Cell’s Point of View Gap Size# of Red Blood Cells Full MagLev1,000μm167 Hydrodynamic Bearing50μm8 6-8 μm Stacked RBCs Chronic Support
17 B HeartMate III*: Full MagLev Technology Key Design Feature: Pulsatility (Minimize stasis) These large gaps also enable the rapid speed changes used by our artificial pulse feature without rotor/housing contact. Some potential benefits: Designed to promote washing of the pump Prevents the formation of zones of recirculation and stasis. Zero Net Change in Flow Speed ramps up and down (zero net change) Potential Clinical Benefits 1-3 For example, a theorized source of bleeding in chronic support with constant-speed rotary pumps involves the development of arteriovenous malformations, a syndrome associated with persistently low pulse pressure FS 0.20 FS-2000 FS+2000 time [ s ] rotor speed [ rpm ] 1.Tsai H. S., et al. Semin Thromb Hemost 2003;29(5): Malehsa D, Meyer AL, Bara C, Struber M. Eur J Cardiothorac Surg 2009;35: Crow S, John R, Boyle A, Shumway S, Liao K, Colvin-Adams M, Toninato C, Missov E, Pritzker M, Martin C, Garry D, Thomas W, Joyce L. J Thorac Cardiovasc Surg 2009;137: Chronic Support
18 L’avenir The future
19 B HeartMate Fully Implanted System* (FILVAS) *In development. Not approved for clinical use MobileTetheredFree The future
20 B HeartMate Fully Implantable System* Flexible Lifestyle Eliminates the driveline and “around the clock” worn equipment. Forgiving Energy Transfer High-efficiency, user-friendly wireless energy transfer across a distance Designed for Advanced Implantation and Robust Battery Technology Custom battery technology tailored for implantable LVAD application – Expected to provide greater than 3 years of life with slow degradation Focus on reduced size and reliability of electronics Mobile Tethered Free Breakthrough technology to advance mechanical circulatory support. *In development. Not approved for clinical use The future
21 B Energy Efficiency and Patient Controller Miniaturized System Controller* Integrated on-board battery* *In development. Not approved for clinical use The future
22 B HeartMate X* *In development. Not approved for clinical use The future
23 B HeartMate ® X* Ultra-Compact, Highly Versatile VAD = New patient populations Potential to meet the needs of earlier stage patients Potential for minimally invasive implantation Potential for multiple configurations (LVAD, RVAD, BiVAD) Expected Benefits Features Utilizes proven HeartMate II bearing technology Partial to Full support (8 L/min) in ultra-compact size Highly energy efficient Miniaturized patient peripherals Left and/or right side assistance *In development. Not approved for clinical use The future
24 B Minimally Invasive and Multiple Configurations LVAD / RVAD / BiVAD *In development. Not approved for clinical use Partial support (design point: 2.5 L/min) Nominal full support (design point: 5.3 L/min) Right sided support (design point: 4.3 L/min) Designed for up to 8 L/min of flow The future
25 B Innovation: Saving More Lives Tomorrow A uniquely robust pipeline of new products HeartMate III* HeartMate X* HeartMate PHP* HeartMate IICentriMag HeartMate FILVAS* *In development. Not approved for clinical use