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Next Generation Cardiac Assist Devices

- 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.

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Next Generation Cardiac Assist Devices

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  1. - Overview - Next GenerationCardiac Assist Devices presented to Society for Medical Innovation and Technology11-14 May 2006Pebble Beach, Monterey, CA, USA Jeffrey L. Helfer

  2. 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

  3. 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

  4. 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

  5. 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) • A “healing environment” that includes means to deliver multiple therapies directly to the heart

  6. 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.

  7. - Summary -A Rx for Acute Heart Failure Rapid MYO-VAD 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

  8. - 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 • Nearly certain to promote re-remodeling • Treats multiple HF conditions, including diastolic and RV failure • Little potential forshort-term or long-term complications. • Full implantability possible Manage chronic HF by better managing acute HF

  9. - 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.

  10. - 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.

  11. 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

  12. Combined Drug-Device Therapies Near-term Applications Intermediate-term Applications Longer-term Applications/Therapies • Anti-arrhythmic drugs • - Membrane stabilizing • drugs (e.g. steroids) • High dose beta blockers • ACE inhibitors • Calcium ion antagonists - Gene therapy - Growth factors - Stem cell therapy • - Para-hormones • - Agents directed against • negative aspects of HF • o MMP inhibition • o Ischemic damage • o Cell apoptosis • - Calcium sensitizers • Endothelin receptor agonists Increased use of existing drugs Reduced regulatory hurdles for new indications of existing drugs Enable adoption of new agents

  13. The Results

  14. 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.

  15. Appendices

  16. 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 Limited applications at specialized transplant and cardiac centers [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.

  17. REMATCH patient survival data 100.0% 80.0% 60.0% Survival rate (%) 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 LVAD Patients 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. 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, While the therapeutic benefit of VADs is exciting, complications severely restrict their use

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