11 B169-0313

Assistance ventriculaire Les produits en développement

Pr Camille DambrinService de chirurgie cardio-vasculaire, CHU Toulouse-Rangueil

2B169-0313

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

33

Assistance à court terme

Acute/Internediate Support

4B169-0313

CentriMag®

Acute/Internediate Support

5B169-0313

CentriMag Recent Additions

2nd Gen Console Surgical Cannulae System Cart Transporter

Available

Acute/Internediate Support

6B169-0313

HeartMate PHP®

*In development. Not approved for clinical use

Acute/Internediate Support

7B169-0313

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

88

Assistance à long terme

Chronic Support

9B169-0313

Chronic Support

10B169-0313

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

12B169-0313

HeartMate II System

Chronic Support

1313

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

14B169-0313

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

15B169-0313

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

16B169-0313

How much diff erence is there?From a Red Blood Cel l ’s Point of View

Gap Size # of Red Blood Cells

Full MagLev 1,000μm 167

Hydrodynamic Bearing 50μm 8

6-8 μm

Stacked RBCs

Chronic Support

17B169-0313

HeartMate III*: Full MagLev TechnologyKey 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 Benefits1-3

• 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

2.00

FS

0.20

FS-2000

FS+2000

time [s]

rotor speed [rpm]

1. Tsai H. S., et al. Semin Thromb Hemost 2003;29(5):479-88.2. Malehsa D, Meyer AL, Bara C, Struber M. Eur J Cardiothorac Surg

2009;35:1091-3.3. 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.

Chronic Support

1818

L’avenir

The future

19B169-0313

HeartMate Fully Implanted System*(FILVAS)

*In development. Not approved for clinical use

Mobile Tethered Free

The future

20B169-0313

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

21B169-0313

Energy Effi ciency and Patient Controller

• Miniaturized System Controller*

• Integrated on-board battery*

*In development. Not approved for clinical use

The future

22B169-0313

HeartMate X*

*In development. Not approved for clinical use

The future

23B169-0313

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

24B169-0313

Minimally Invasive and Multiple Confi gurationsLVAD / 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

25B169-0313

Innovation: Saving More Lives Tomorrow

A uniquely robust pipeline of new products

HeartMate III* HeartMate X* HeartMate PHP*

HeartMate II CentriMagHeartMate FILVAS*

*In development. Not approved for clinical use