Transcript Chronic Support

Assistance ventriculaire
Les produits en développement
Pr Camille Dambrin
Service de chirurgie cardio-vasculaire, CHU Toulouse-Rangueil
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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
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Acute/Internediate Support
Assistance à court terme
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Acute/Internediate Support
CentriMag®
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Acute/Internediate Support
CentriMag Recent Additions
2nd Gen Console Surgical Cannulae
System Cart
Transporter
Available
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Acute/Internediate Support
HeartMate PHP®
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*In development. Not approved for clinical use
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Acute/Internediate Support
HeartMate PHP*
Cardiac Catheter Pump
•Low-profile percutaneous device delivered through
13F sheath
•Expands to 24F across aortic valve
Target Applications
• Acute MI
• Cardiogenic Shock
• High-risk PCI
• Acutely decompensated heart failure
•Designed to deliver over 4 lpm for up to 10 days
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*In development. Not approved for clinical use
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Chronic Support
Assistance à long terme
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Chronic Support
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Chronic Support
Power Unit Evolution
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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 (6,4m)
• 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
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Chronic Support
HeartMate II System
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Chronic Support
HeartMate III
with Full MagLev™
®
Designed with a Healthy Respect for the Blood
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13 *Caution:
Investigational device. Limited by Federal US law to investigational use
Chronic Support
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)
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Chronic Support
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
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Chronic Support
How much difference is there?
From a Red Blood Cell’s Point of View
6-8 μm
Full MagLev
Hydrodynamic Bearing
Gap Size
# of Red Blood Cells
1,000μm
167
50μm
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Stacked RBCs
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Chronic Support
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
•
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 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
time [s]
0.20
2.00
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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.
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The future
L’avenir
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The future
HeartMate Fully Implanted System*
(FILVAS)
Mobile
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Tethered
Free
*In development. Not approved for clinical use
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The future
HeartMate Fully Implantable System*
Breakthrough technology to advance mechanical circulatory support.
Forgiving Energy Transfer
Mobile
Tethered
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.
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• 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
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The future
Energy Efficiency and Patient Controller
• Miniaturized
System Controller*
• Integrated
on-board battery*
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*In development. Not approved for clinical use
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The future
HeartMate X*
*In development. Not approved for clinical use
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The future
HeartMate ® X*
Ultra-Compact, Highly Versatile VAD = New patient populations
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
Expected Benefits
• Potential to meet the needs of earlier stage patients
• Potential for minimally invasive implantation
• Potential for multiple configurations (LVAD, RVAD, BiVAD)
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The future
Minimally Invasive and Multiple Configurations
LVAD / RVAD / B iVAD
Designed for up to 8 L/min of flow
 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)
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*In development. Not approved for clinical use
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Innovation: Saving More Lives Tomorrow
A uniquely robust pipeline of new products
HeartMate II
HeartMate III*
HeartMate FILVAS*
HeartMate X*
CentriMag
HeartMate PHP*
*In development. Not approved for clinical use
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