Download Cardiovascular Division Overview Presentation

- Overview -
Next Generation
Cardiac Assist Devices
presented to
Society for Medical Innovation and Technology
11-14 May 2006
Pebble Beach, Monterey, CA, USA
Jeffrey L. Helfer
Heart Failure…Our Focus
Each year, about 1 million people die from HF in the U.S.
There are many medical approaches for treating heart
failure – all of which have serious limitations!
• Conventional emergency resuscitation
• Traditional drug therapy
• Ventricular Assist Devices (VADs)
• Intra-aortic balloon pumps (IABP)
• Transplant and Total artificial heart
To achieve a significant improvement in outcome
requires a paradigm shift in treatment methods
2 •
The Paradigm Shift
A safer and more effective treatment that addresses both
short term support and recovery:
• Short-term support, e.g. minimize ischemic damage
• Longer-term support (when necessary) to enable recovery of
the heart and (ultimately) removal of the device/therapy
A therapy that is also;
• Cost effective (total procedure cost)
• Broadly available - not just at specialized cardiac centers
• Reimbursable under existing guidelines
• Permits effective delivery of multiple therapeutic agents
3 •
The Product
Approach: Utilize the best blood pump ever
developed – the native human heart!
How it Works (Gen-1 Product)
• Polymer cup that slips over the heart
• Installed via a small chest incision.
• Attached to and driven by a small
external pump
• Sustains natural pulsatile flow
This technology has already saved human lives
4 •
Unique Product Capabilities
1. No contact with circulating blood
(Avoids clotting and stroke, bleeding, and infection)
2. Systolic and diastolic support to both ventricles
(Treats many types of heart failure)
3. Enhanced myocardial perfusion (Minimizes ischemic injury)
4. Normal pulsatile flow (More effective reperfusion)
5. Supports all sizes of hearts in many acute and chronic diseases
6. Rapid, technically simple installation and removal
(Available at virtually all hospitals)
7. A “healing environment” that includes means to deliver
multiple therapies directly to the heart
5 •
Clinical and Pre-clinical Results
1. Supported 45-year old for 2 days following massive myocardial infarction
with no damage to the heart.
2. Supported 71-year old for 2 days following heart surgery
with no damage to the heart or by-pass grafts.
3. Supported 56-year old for 2-1/2 days as bridge to successful transplantation
with no damage to native heart.
4. Supported 18-year old for 7-1/2 days until heart healed from a viral myocarditis
with no damage to the heart.
5. Supported 44-year old for 84 days with normal neurologic function
with no damage to the heart.
In addition to human studies, over 700 animal experiments have been conducted to develop
and patent the means to safely and effectively support human hearts while simultaneously
providing a wide array of additional operational, diagnostic, and therapeutic capabilities.
6 •
- Summary -
A Rx for Acute Heart Failure
Rapid Myotech Circulatory Support System (CSS) intervention
(e.g. post-MI) can limit the extent and degree of ischemia in
cardiac tissue and limit infarct size:
• Reduce LV/RV workload so that marginally perfused myocardium
can survive
• Enhance cardiac reperfusion
- Increased coronary flow
- Maintain perfusion pressure by preventing shock
- Improved thrombolysis due to enhanced delivery of lysis agents
• Increase blood O2 concentration
- Increasing perfusion volume of the lungs
- Decrease myocardial O2 requirements by cooling the heart
7 •
- Summary -
A Rx for Chronic Heart Failure
High potential for recovery of normal cardiac function:
- Immediate pumping support
- Offload mechanical stress on the heart the basic mechanism
that triggers the complex remodeling cascade
- Adaptive constraint maintains low mechanical stress
- Enhanced drug therapy capability
- Mechanical “training” of a weakened heart
Manage
chronic HF
by better
managing
acute HF
Nearly certain to promote re-remodeling
Treats multiple HF conditions, including diastolic and RV failure
Little potential for short-term or long-term complications.
Full implantability possible
8 •
- Briefly -
Infarct Expansion in Ventricle
LV Before Infarct
LV After Infarct
During acute MI, the initial loss of contractile tissues adversely affects
workload and wall stress on the remaining viable myocardium, providing a
“substrate” for progressive ventricular enlargement.
9 •
- Briefly -
Relative Risk for Death in MI Survivors
For each 25-mL increment in
end-systolic volume, the risk
for death increased
exponentially over that of
other survivors of myocardial
infarction with preserved left
ventricular volume.
White HD, Norris RM, Brown MA, et al.: Left
ventricular end-systolic volume as the major
determinant of survival after recovery from
myocardial infarction. Circulation 1987, 76: 44–51.
Factors that influence ventricular remodeling after MI can be modified
to improve clinical outcome.
Limiting the extent of ventricular remodeling in asymptomatic patients after MI can
be considered as preventive therapy for symptomatic congestive heart failure.
10 •
Drug Delivery Capability
1. Cardiac-directed
- Delivery of agents directly to the heart
- Local concentrations that cannot be achieved,
maintained or tolerated systemically
2. Continuous delivery (optimize pharmacokinetics)
3. Enhanced transfer rates
- “Open channels” to the myocardium
- The normal mechanism for delivering agents/signals to cells
4. Supportive micro-environment (delivery of nutrients)
Improved regional effects with less adverse systemic reaction
11 •
Combined Drug-Device Therapies
Near-term
Applications
Intermediate-term
Applications
Longer-term
Applications/Therapies
- Anti-arrhythmic drugs
- Para-hormones
- Gene therapy
- Membrane stabilizing
drugs (e.g. steroids)
- Agents directed against
negative aspects of HF
- Growth factors
- High dose beta blockers
- ACE inhibitors
- Calcium
ion antagonists
o MMP inhibition
o Ischemic damage
o Cell apoptosis
- Stem cell therapy
- Calcium sensitizers
- Endothelin receptor agonists
Increased use of
existing drugs
12 •
Reduced regulatory
hurdles for new indications
of existing drugs
Enable adoption of
new agents
The Results
13 •
Anticipated Indications for Use
Bridge-to-Recovery
Provides short-term support while the heart heals from moderate injury. A very important and
growing market.
Acute Resuscitation
Important rapid recovery during cardiac emergencies and maintaining cardiac output for short
periods of time. Significantly expanded market segment.
Bridge-to-Transplant
Keeps patients alive until a new heart is available.
Destination Therapy
Permanent support. Huge potential for MYOTECH since other current design VAD problems
severely limit usage. Significantly expanded market segment.
Therapeutic Recovery
Longer-term support from serious disease or injury. The potential for many hearts to recover,
allowing device removal. A new market segment.
14 •
Appendices
15 •
Current Cardiac Assist Device Technology
Benefits
Systolic support of a single ventricle
Increase coronary perfusion and oxygen
delivery via increased systemic pressure
Patient mobility
Problems
Perforates the heart and great vessels
High risk of patient complications due to
clotting and stroke, bleeding, and
infection
Average procedure cost: $205,8001
[1] Oz. M., Annetine, C., Miller L. et al., Left Ventricular Assist Devices as
permanent Heart Failure Therapy: The price of progress, Annals of
Surgery. 238(4): 577-83, October 2003.
16 •
Limited applications at specialized
transplant and cardiac centers
Validation of the Cardiac Assist Device Market
Ventricular Assist Devices or “VADs” have already been shown to be
superior to medical management for the treatment of heart failure.
Survival rate (%)
REMATCH patient survival data
100.0%
80.0%
60.0%
40.0%
20.0%
0.0%
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31
Month
OMM Patients
The huge investment in VAD
technologies continues to be
a great indication of the
potential of this market despite serious short term
and long term complications,
LVAD Patients
While the therapeutic benefit of VADs is exciting,
complications severely restrict their use
17 •