Transcript Realizing the New Era Thoratec® Product Development

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
More than 18,000 patients implanted worldwide
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Product Development Strategy Overview
Next-Generation Pumps
HeartMate II Evolution
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Maintain HeartMate II as the
best-in-class LVAD
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GoGear Peripherals
Driveline durability
Sealed grafts
G2 System Controller
LV attachment tools
Mobile Power Unit
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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
Cross-Platform
Breakthrough Technologies
•
Introduce technologies
which substantially enhance
MCS therapy for both
patients and clinicians,
supporting both HeartMate II
leadership and future pump
platforms
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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
HeartMate II® Evolution
Next-Generation Pumps
Cross-Platform Breakthrough
Technologies
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HeartMate II ® Product Evolution – Projected Timelines
2009
2010
2011
GoGear
Peripherals
2012
Worldwide
Commercial
Launch
Driveline
Durability
Sealed
Grafts
G2
Controller
Surgical Tools –
LV Attachment
Mobile Power Unit
Initiating
Development
MPU
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HeartMate GoGear System Components
Battery
Charger
HeartMate GoGear
System Components
(Launched 2009)
14 volt Batteries
and Clips (Li-Ion)
Redesigned system
components support a
patient’s recently restored
active lifestyle, providing
mobility and flexibility in a
safe and secure manner
Power Module
Smart
Controller
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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.
Sealed Outflow Graft
• 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
Sealed Inflow Conduit
– articulation allows adaptation
and variety of VAD placement
options
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HeartMate II G2 System Controller
Advanced System Controller
Front
(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
Weight (g)
Dimensions (cm)
Volume (cm3)
Backup Power
LCD Screen
G1 Controller
G2 Controller
~635
19.0 x 9.7 x 3.6
~660
~360
13.0 x 7.7 x 3.0
~300
No
No
Yes
Yes
Back
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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
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HeartMate Mobile Power Unit
Indicators provide reassurance of
device function
A/C Power
MPU
MPU body incorporates
cable management
capability
21’ power lead
(fully extended)
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
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Agenda
HeartMate II® Evolution
Next-Generation Pumps
Cross-Platform Breakthrough
Technologies
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Next-Generation Pump – Projected Timelines
2011
2012
2013
2014
HeartMate III
First-In-Man
PHP
HeartMate X
Also in
Development
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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
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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
Targeted Applications
• Unstable AMI
• High-risk PCI
• Acutely decompensated
heart failure
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Potentially other patient
populations
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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
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Agenda
HeartMate II® Evolution
Next-Generation Pumps
Cross-Platform Breakthrough
Technologies
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Cross-Platform Technologies
2011
2012
2013
2014
Fully Implantable
System
First-In-Man
Infection
Reduction
Automated
Anastomosis
Wireless
Architecture
Remote
Monitoring
Also in
Development
Patient Information
via
web page
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Fully-Implantable LVAS (FILVAS)
Fully Implantable System
(Finalizing Design)
Energy
Transfer Coil
• No percutaneous lead – improved infection and
system durability profile
Configured with
choice of pump
• 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
Implanted
Controller
Implanted
Battery
• Reduced size Implanted components with highly
reliable electronics
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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 lateonset infection
Force (lb)
Maximum Force at Cutaneous
Tissue Separation
• Advanced exit site material morphology
and chemistry for improved tissue /
percutaneous lead interface
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10
5
0
Control
Test
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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
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HeartMate Wireless Architecture
Current
Future
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**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
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Remote Monitoring
Home or Office
Home
Data
Internet
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
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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 maintenancefree 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
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MERCI DE VOTRE
ATTENTION
Hommage à celles qui ont travaillé
au sein du Bureau au fil du temps