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

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Product Development Strategy Overview

HeartMate II Evolution Next-Generation PumpsCross-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

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Agenda

Next-Generation Pumps

Cross-Platform Breakthrough Technologies

HeartMate II® Evolution

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HeartMate II® Product Evolution – Projected Timelines

Sealed Grafts

G2Controller

Surgical Tools – LV Attachment

2011 20122009

GoGearPeripherals

Driveline Durability

2010

Worldwide Commercial

Launch

Mobile Power Unit

InitiatingDevelopment

MPU

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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 patient’s 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 patient’s recently restored active lifestyle, providing mobility and flexibility in a safe and secure manner

SmartController

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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

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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

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

G1 Controller G2 Controller

Weight (g) ~635 ~360Dimensions (cm) 19.0 x 9.7 x 3.6 13.0 x 7.7 x 3.0Volume (cm3) ~660 ~300

Backup Power No Yes

LCD Screen No Yes

Front

Back

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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

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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

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Agenda

Next-Generation Pumps

Cross-Platform Breakthrough Technologies

HeartMate II® Evolution

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Next-Generation Pump – Projected Timelines

2011 2012 2013 2014

First-In-ManHeartMate III

PHP

HeartMate X

Also in Development

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HeartMate IIIUltra-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

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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

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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

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Agenda

Next-Generation Pumps

Cross-Platform Breakthrough Technologies

HeartMate II® Evolution

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Cross-Platform Technologies

2011 2012 2013 2014

Fully Implantable System

First-In-Man

AutomatedAnastomosis

Also in Development

Infection Reduction

RemoteMonitoring

Wireless Architecture

Patient Information

via web page

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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

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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

Maximum Force at Cutaneous Tissue Separation

0

5

10

15

Control Test

Fo

rce

(lb

)

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Automated Anastomosis

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

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

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HeartMate Wireless Architecture

Current Future

**Both SM and PM are required for in-clinic programming and monitoring

**

HeartTouchTablet Computer

WirelessSystem 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

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Remote Monitoring

WirelessSystem Controller

LVAD Patient

HomeHome 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

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PVAD & IVAD Product Development

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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

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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

MERCI DE VOTRE

ATTENTION

20ième congrès AFICCT

Hommage à celles qui ont travaillé au sein du Bureau au

fil du temps