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The New Era Begins

HeartMate II ® Left Ventricular Assist System (LVAS). The New Era Begins. Contents. Introducing the HeartMate II Indications for use Clinical experience. HeartMate II LVAS. A surgically implanted, rotary continuous-flow device in parallel with the native left ventricle

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The New Era Begins

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  1. HeartMate II® Left Ventricular Assist System (LVAS) The New Era Begins

  2. Contents • Introducing the HeartMate II • Indications for use • Clinical experience

  3. HeartMate II LVAS A surgically implanted, rotary continuous-flow device in parallel with the native left ventricle Left ventricle to ascending aorta Percutaneous driveline Electrically powered Batteries & line power Fixed speed operating mode Home discharge

  4. Benefits of a Rotary Device • Smaller size • 60% Smaller than HeartMate I (XVE) • 35 mm diameter • 70 mm long • 280 grams • No requirement for venting • 40% reduction in the size of percutaneous lead • Enhanced patient comfort • Silent, vibration-free operation • Ease of surgical implantation • Standard sternotomy vs. extended midline excision • Smaller preperitoneal pocket • Designed for extended durability

  5. Key Design Features Elegant Design Valveless Only one moving part, the rotor Blood immersed bearings designed for minimization of blood damage All motor drive and control electronics are outside of the implanted blood pump Two piece outflow conduit Speed range: 6,000 to 15,000 rpm Flow range: 3 – 10 L/min

  6. System Components Implanted Components: Implantable titanium blood pump External Components: System Controller System Monitor Display Module Power Sources Power Module Batteries & Clips Emergency Power Pack Accessories

  7. HeartMate II LVAS Pump • Flexible inflow conduit • Textured surfaces • Inlet cannula, inflow and outflow elbows • Thrombo-resistant • Outflow graft with bend relief • Anastomosed to LV apex and ascending aorta • Pump output varies over cardiac cycle • Follows native pulse • Afterload sensitive

  8. HM II Pump External View Outflow Graft (14 mm) Inflow Conduit (20 mm) Bend Relief • Flex Section • Pre-clotted, knitted polyester graft • Titanium ring • Silastic sleeve Percutaneous lead (8 mm) Blood Pump

  9. Pump Rotor and Stators Flow Inflow Stator Rotor Outflow Stator Outflow Bearing Inflow Bearings

  10. HM II System Controller Microprocessor that: • Delivers power to the pump • Controls pump speed and power • Monitors, interprets & responds to system performance • Performs diagnostic monitoring • Indicates hazard and advisory alarms • Provides complete backup system • Automatic event recording • Data logger capabilities

  11. HeartMate II Power Sources • AC power from Power Module (PM) • DC power from a pair of 14-volt lithium-ion batteries and clips • DC power from the Emergency Power Pack (EPP)

  12. 14-Volt Lithium-Ion Batteries • Full work day of support on a single charge (10 hours per pair) • Weigh approx 1 pound each • Smart technology results in optimal charging, accurately gauges charge level and ensures battery lifespan (up to three years) • Four hour recharge for fully discharged battery

  13. Universal Battery Charger • Rapid charging (4 hours for 4 batteries) minimizes the number of batteries required for excursions – reduces the burden of battery management • Continuous diagnostic testing and automatic calibration delivers consistent battery performance • Intuitive light indicators provide readily-accessible battery status • Highly portable – 8 pounds

  14. Power Module • Supplies AC power to HM II • Provides 30 minutes of backup power in case of AC power failure • Simple, effective light indicators and audio alarms give immediate feedback on system operation • Automobile port offers patients the added convenience of “plugging in” while in the car • Repeats alarms generated by the System Controller • Powers the System Monitor and Display Module for system programming and monitoring purposes

  15. Emergency Power Pack • Single use battery pack enclosed in a plastic carrying case with a shoulder strap • Provides battery power to the HM II in the event of extended power outage • Approximately 12 hours of support • Must be replaced if used for a period exceeding three hours

  16. Shared HeartMate Components System Monitor Provides data about HM II function when the patient is on tethered operation Six screens, touch interface The only place in the system where the fixed rate setpoint and low speed limit can be adjusted Ability to download HM II data & view system controller event recorder Appropriate software implemented upon system controller connection Display Module Provides a display of system performance (pump rate, pulsatility, flow,and alarms)

  17. Contents • Introducing the HeartMate II • Indications for use • Clinical experience

  18. Indications for Use • Bridge to Transplant • Non-reversible left heart failure • Imminent risk of death • Candidate for cardiac transplantation • Destination Therapy • NYHA Class IIIB or IV heart failure • Optimal medical therapy 45 of last 60 days • Not candidate for cardiac transplantation • For in-patient and out-patient use

  19. Considerations • No trial data on BSA < 1.3 m², use medical judgment • Limited data on pediatric patients (Age < 18 years) • Ability to tolerate / allergy toward anticoagulation • Social support • Acceptance of blood products • Pregnancy • Nonreversible end organ failure

  20. Contents • Introducing the HeartMate II • Indications for use • Clinical experience

  21. Worldwide Clinical Experience* More than 10,000 patients worldwide have now been implanted with the HeartMate II LVAS. • 2-3 years = 1151 • 3-4 years = 428 • 4-5 years = 174 • 5-6 years = 73 • 6-7 years = 19 • 7 -8 years = 3 • 8-9 years = 1 (ongoing) As of June 2012 *Based on clinical trial and device tracking data

  22. Worldwide Clinical Experience > 10,000 Patients Implanted Pilot Trial n=53 Pivotal Trial n=1315* *as treated Commercial Experience n>9000 (+114 XVEs) Bridge to Transplant n=490 Destination Therapy n=825 BTT Approvals DT Approvals CE Mark: Nov. 2005 CE Mark: Nov. 2005 FDA: Apr. 2008 FDA: Jan. 2010 Health Canada: May 2009 Health Canada: Nov. 2010 As of Apr 2012

  23. Summary of BTT Outcomes

  24. BTT Actuarial Survival Post Approval Study a John et al.ATS 2011 b Starling et al JACC 2011 d Pagani et al JACC 2009 e Miller et al NEJM 2007

  25. Study Backgrounds Post-Approval Study1 • Initiated post-BTT approval to assess outcomes in a broader patient care environment • First approved study to use INTERMACS • The first 169 consecutive HM II patients enrolled in INTERMACS • Listed or likely to be listed for transplant • Enrolled across 77 centers from April to August 2008 • Patients followed for at least 1 year Post-trial Study2 • Assess outcomes in a broad, commercial setting • 1496 commercial HM II patients enrolled in INTERMACS • Enrolled across 83 centers from April 2008 to Sept 2010 • Listed or likely to be listed for transplant • Patients followed for at least 1 year 1. Starling RC, Naka Y, Boyle AJ, et al. Results of the Post-U.S. Food and Drug Administration-Approval Study With a Continuous Flow Left Ventricular Assist Device as a Bridge to Heart Transplantation. JACC 2011; 57(19): 1890-8. 2. John R, Naka Y, et. al. Continuous Flow Left Ventricular Assist Device Outcomes in Commercial Use Compared with the Prior Clinical Trial. Ann Thorac Surg 2011; 92:1406-13.

  26. Study Endpoints & Quality of Life • Primary Endpoint: • Survival • Secondary Endpoint • Adverse events • Reported upon occurrence • Quality of Life • EuroQol scale determined at baseline and 3, 6, and 12 months post-implant

  27. Demographics, Patient Characteristics & INTERMACS Profiles • 60+% of commercial HM II patients were in INTERMACS profiles 1 & 2 1. John R, Naka Y, et. al. Continuous Flow Left Ventricular Assist Device Outcomes in Commercial Use Compared with the Prior Clinical Trial. Ann ThoracSurg 2011; 92:1406-13. 2. Starling RC, Naka Y, Boyle AJ, et al. Results of the Post-U.S. Food and Drug Administration-Approval Study With a Continuous Flow Left Ventricular Assist Device as a Bridge to Heart Transplantation. JACC 2011; 57(19): 1890-8.

  28. Adverse Events Patients in the commercial environment experienced a reduced or similar rate of adverse events in a broader patient care environment compared to clinical trial patients. Only 10% of HM II patients in a commercial setting had GI bleeding3 1. John R, Naka Y, et. al. Continuous Flow Left Ventricular Assist Device Outcomes in Commercial Use Compared with the Prior Clinical Trial. Ann ThoracSurg 2011; 92:1406-13. 2. Starling RC, Naka Y, Boyle AJ, et al. Results of the Post-U.S. Food and Drug Administration-Approval Study With a Continuous Flow Left Ventricular Assist Device as a Bridge to Heart Transplantation. JACC 2011; 57(19): 1890-8.

  29. Study Outcomes 1. John R, Naka Y, et. al. Continuous Flow Left Ventricular Assist Device Outcomes in Commercial Use Compared with the Prior Clinical Trial. Ann ThoracSurg 2011; 92:1406-13. 2. Starling RC, Naka Y, Boyle AJ, et al. Results of the Post-U.S. Food and Drug Administration-Approval Study With a Continuous Flow Left Ventricular Assist Device as a Bridge to Heart Transplantation. JACC 2011; 57(19): 1890-8. • Survival was 89-90% at 6-months and 85% at 12-months • The difference between commercial and trial groups was statistically significant • Higher percentage of patients continuing on device support at 1 year in the posttrial group versus the trial. • 45% vs. 32%, respectively

  30. Quality of Life Improvements seen here from the post-trial study with ~1500 patients are consistent with the improvements observed during the pivotal trial and the post-approval study John R, Naka Y, et. al. Continuous Flow Left Ventricular Assist Device Outcomes in Commercial Use Compared with the Prior Clinical Trial.Ann Thorac Surg 2011; 92:1406-13.

  31. Discussion/Conclusions • The HM II post-approval & post-trial studies demonstrate a significant improvement in survival outcomes in a broader patient care setting. • Dramatic improvements in QoL, first seen during the BTT pivotal trial, continue to be observed • Factors contributing to improving trends: • Improved timing of patient referral • Better patient selection • Enhanced implantation techniques • Improved post-op patient management • Increased knowledge and team training • Higher surgery volume • More dedicated coordinators and experienced patient care teams

  32. Summary of DT Outcomes

  33. Improvements in DT Survival Early Trial vs Mid Trial * P value adjusted for body surface area Park, S, et al Circ Heart Fail 2012.

  34. DT Trial CAP: Background Background Survival in Destination Therapy Trials2 • Initial HeartMate II Destination Therapy (DT) trial demonstrated significant improvements in outcomes compared to randomized patients with pulsatile LVADs1 • 68% survival at 1 year • 58% survival at 2 years • Over 500 additional DT patients have been enrolled under continued access protocol (CAP) 1 Slaughter MS, Rogers JG, Milano CA et al: Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009 Dec 3;361(23):2241-51. 2 Fang JC: Rise of Machines – Left Ventricular Assist Devices as Permanent Therapy for Advanced Heart Failure N Engl J Med. 2009 Dec 3;361(23):2282-84. Park, S, et al Circ Heart Fail 2012.

  35. DT Trial CAP: Overview & Baseline Trial Overview and Baseline Characteristics Park, S, et al Circ Heart Fail 2012.

  36. DT Trial CAP: Adverse Event Summary Improvements in Adverse Event Rates: Early to Mid Trial Stroke (events per pt-year) Relative Risk Ratio * Infection (events per pt-year) *p<0.05 **p<0.01 ** * Park, S, et al Circ Heart Fail 2012.

  37. DT Trial CAP: Functional Class Improvements 6-Minute Walk Test and NYHA Functional Class I & II Park, S, et al Circ Heart Fail 2012.

  38. DT Trial CAP: Conclusions & Inference Conclusions What is the magnitude of absolute survival benefit with LVAD DT therapy? • Trend towards improving survival • Fewer deaths from hemorrhagic stroke • Significant reductions in adverse events: • Hemorrhagic stroke >50% reduction • Device related infections >35% reduction • Sepsis >25% reduction • Both QoL measures (KCCQ and MLWHF) demonstrated significant improvement over baseline values 73% 63% Source: Park SJ, AHA 2010

  39. Appendix Appendix A: BTT Pivotal Trial Outcomes

  40. BTT Commercial Outcomes INTERMACS Annual Report Jan 2010 – 88% Survival (n=548) Kirklin JK et al: JHLT 2010

  41. HeartMate II Pivotal Trial • FDA approved Investigational Device Exemption (IDE) for two clinical studies: • Bridge to Transplantation (BTT) – patients enrolled at 33 sites • Primary cohort enrollment completed May, 2006 • Six month follow-up completed November, 2006 • Approved April, 2008 • Destination Therapy (DT) – patients enrolled at 38 sites • Randomized 2:1; HeartMate II vs. HeartMate I • Primary cohort enrollment completed May, 2007 • Two year follow-up completed May, 2009 • Approved January, 2010

  42. BTT Clinical Trial Entry Criteria • New York Heart Association Class IV heart failure symptoms • Transplant listed 1A or 1B (if 1B meet hemodynamic criteria) • On inotropic support • No severe end-organ dysfunction/failure • Ability to tolerate anticoagulant or antiplatelet therapies • No moderate to severe aortic insufficiency without plans for correction

  43. BTT Clinical Trial Design • Multicenter, non-blinded, non-randomized, prospective study • Primary outcomes were death, transplantation, myocardial recovery, or survival to 180 days on LVAS support. • Secondary outcomes included functional status, quality of life, 30-day and 1-year post-transplant survival

  44. BTT Clinical Trial • Bridge to Transplant (n=281)* • Primary Cohort • 133 pts at 26 sites • Enrollment: March 2005 to May 2006 • CAP (Continued Access Protocol) Cohort • 148 patients at 32 sites • Enrollment: May 2006 to April 2008 * Patients implanted with at least 18 month follow up.

  45. HeartMate II Initial BTT Results (n=133) NEJM 2007;357:885-96.

  46. HeartMate II BTT Long-term Results (n=281) JAAC 2009;54(4):312-21.

  47. BTT Clinical Trial Outcomes • Primary Study Outcomes • Transplantation • Ongoing device support • Recovery of ventricular function and device explantation Pagani F, Miller L, Russell S, JAAC: Vol 54, No 4, 2009.

  48. BTT Clinical Trial Outcomes • Secondary Outcomes • Overall survival to transplantation • Frequency of adverse events • Functional Status (NYHA, 6 minute walk) • Quality of Life (MLWHF, KCCS) • Survival following transplantation (30 d and 1 yr) Pagani F, Miller L, Russell S, JAAC: Vol 54, No 4, 2009.

  49. Patient Demographics (n=281) Pagani F, Miller L, Russell S, JAAC: Vol 54, No 4, 2009.

  50. Baseline Data (n=281) Pagani F, Miller L, Russell S, JAAC: Vol 54, No 4, 2009.

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