Assistance ventriculaire Les produits en dveloppement Pr Camille

Assistance ventriculaire Les produits en développement Pr Camille Dambrin Service de chirurgie cardio-vasculaire, CHU Toulouse-Rangueil 1 B 169 -0313

Thoratec Corporation Lead the use of Mechanical Circulatory Support (MCS) to dramatically improve outcomes for patients with advanced heart failure Market leadership across the spectrum of MCS Our Values / Our Commitments § Continual improvement of clinical outcomes § Transparent, rigorous clinical research § Increasing awareness and education Vision for and commitment to the future of MCS § Technology innovation leadership 2 B 169 -0313

Acute/Internediate Support Assistance à court terme 3 3

Acute/Internediate Support Centri. Mag® 4 B 169 -0313

Acute/Internediate Support Centri. Mag Recent Additions 2 nd Gen Console Surgical Cannulae System Cart Transporter Available 5 B 169 -0313

Acute/Internediate Support Heart. Mate PHP® 6 *In development. Not approved for clinical use B 169 -0313

Acute/Internediate Support Heart. Mate PHP* Cardiac Catheter Pump • Low-profile percutaneous device delivered through 13 F sheath • Expands to 24 F across aortic valve • Designed to deliver over 4 lpm for up to 10 days 7 *In development. Not approved for clinical use Target Applications • Acute MI • Cardiogenic Shock • High-risk PCI • Acutely decompensated heart failure B 169 -0313

Chronic Support Assistance à long terme 8 8

Chronic Support 9 B 169 -0313

Chronic Support Power Unit Evolution 10 B 169 -0313

Chronic Support Mobile Power Unit (MPU)* Designing for Portable and Patient-Friendly VAD Power Expected Benefits • Enhanced Functionality • Easier patient management (1, 3 kg) • Improved mobility and cable management • Low maintenance (only AAA batteries) • Long cable (6, 4 m) • Safety Design • Echoes System Controller alarms (even if power is lost) • Internal Diagnostics • Improved durability • Twist resistant cables Program Status • Commercial use targeted for june 2015 11

Chronic Support Heart. Mate II System 12 B 169 -0313

Chronic Support Heart. Mate III with Full Mag. Lev™ ® Designed with a Healthy Respect for the Blood 13 13 *Caution: Investigational device. Limited by Federal US law to investigational use

Chronic Support What is Full Mag. Lev? 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) 14 B 169 -0313

Chronic Support Heart. Mate III*: Full Mag. Lev™ Technology Key Design Features: Large and Consistent Gaps (Designed to minimize Shear Stress and Blood Component Activation) – Heart. Mate 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. – Heart. Mate 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 15 B 169 -0313

Chronic Support How much difference is there? From a Red Blood Cell’s Point of View 6 -8 μm Full Mag. Lev Hydrodynamic Bearing Gap Size # of Red Blood Cells 1, 000μm 167 50μm 8 Stacked RBCs 16 B 169 -0313

Chronic Support Heart. Mate III*: Full Mag. Lev 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 • rotor speed [rpm] Prevents the formation of zones of recirculation and stasis. FS+2000 FS FS-2000 • 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 0. 15 time [s] 0. 20 2. 00 1. 2. 3. Tsai H. S. , et al. Semin Thromb Hemost 2003; 29(5): 479 -88. Malehsa D, Meyer AL, Bara C, Struber M. Eur J Cardiothorac Surg 2009; 35: 1091 -3. 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: 208 -15. 17 B 169 -0313

The future L’avenir 18 18

The future Heart. Mate Fully Implanted System* (FILVAS) Mobile 19 Tethered Free *In development. Not approved for clinical use B 169 -0313

The future Heart. Mate Fully Implantable System* Breakthrough technology to advance mechanical circulatory support. Mobile Tethered Forgiving Energy Transfer Free • High-efficiency, user-friendly wireless energy transfer across a distance Designed for Advanced Implantation and Robust Battery Technology Flexible Lifestyle Eliminates the driveline and “around the clock” worn equipment. 20 • 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 *In development. Not approved for clinical use B 169 -0313

The future Energy Efficiency and Patient Controller • Miniaturized System Controller* • Integrated on-board battery* 21 *In development. Not approved for clinical use B 169 -0313

The future Heart. Mate X* *In development. Not approved for clinical use 22 B 169 -0313

The future Heart. Mate ® X* Ultra-Compact, Highly Versatile VAD = New patient populations Features • Utilizes proven Heart. Mate 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 Expected Benefits • Potential to meet the needs of earlier stage patients • Potential for minimally invasive implantation • Potential for multiple configurations (LVAD, RVAD, Bi. VAD) 23 *In development. Not approved for clinical use B 169 -0313

The future Minimally Invasive and Multiple Configurations LV AD / RVAD / Bi. VAD Designed for up to 8 L/min of flow ü Partial support (design point: 2. 5 L/min) ü Nominal full support (design point: 5. 3 L/min) ü Right sided support (design point: 4. 3 L/min) 24 *In development. Not approved for clinical use B 169 -0313

Innovation: Saving More Lives Tomorrow A uniquely robust pipeline of new products Heart. Mate III* Heart. Mate FILVAS* Heart. Mate X* Centri. Mag Heart. Mate PHP* *In development. Not approved for clinical use 25 B 169 -0313