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European Society of Cardiology Congress 2012 Munich, Germany

ACCESS-EUROPE Phase I A Post Market Study of the MitraClip System for the Treatment of Significant Mitral Regurgitation in Europe: Analysis of Outcomes at 1 Year Wolfgang Schillinger, MD on behalf of the ACCESS EU investigators. European Society of Cardiology Congress 2012 Munich, Germany.

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European Society of Cardiology Congress 2012 Munich, Germany

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  1. ACCESS-EUROPE Phase I A Post Market Study of the MitraClip System for the Treatment of Significant Mitral Regurgitation in Europe: Analysis of Outcomes at 1 Year Wolfgang Schillinger, MD on behalf of the ACCESS EU investigators European Society of Cardiology Congress 2012 Munich, Germany

  2. Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.

  3. Transcatheter Mitral Valve RepairMitraClip® System

  4. MitraClip TherapyWorldwide Clinical Experience • Over 6,000 patients have been treated with the MitraClip device worldwide: • 75% are considered high risk* for mitral valve surgery • 67% have functional mitral regurgitation (MR) • 1,905 patients have been enrolled in prospective clinical trials worldwide: • 50% are considered high risk* for mitral valve surgery • 60% have functional MR Estimates of worldwide clinical experience as of 7/20/2012. * Determination of high surgical risk based on: logistic EuroSCORE ≥ 20%, or STS calculated mortality ≥ 12%, or pre-specified high surgical risk co-morbidities specified in EVEREST II High Risk Study protocol.

  5. Introduction • The ACCESS-EUROPE (ACCESS-EU) Study is a two-phase prospective, observational, multicenter, post-approval study of the MitraClip® System for the treatment of significant MR • ACCESS-EU Phase I enrollment started on October 2, 2008 and closed on April 13, 2011. The last follow-up occurred on June 15, 2012. • ACCESS-EU Phase II was initiated on September 15, 2011

  6. Purpose To present 1-year outcomes in patients with significant MR treated with the MitraClip device in the ACCESS-EU Phase I Trial To highlight data, including: Procedural and 30 day safety 1-year outcomes Kaplan-Meier freedom from death MR, NYHA Functional Class and QOL (MLWHF) 6 Minute Walk distance

  7. Enrolling Centers: ACCESS EU Phase I 14 centers have enrolled MitraClip patients

  8. Patient Accountability 1 Year Follow-up N = 487 MitraClip Patients Treated in ACCESS-EU N = 567 N = 3 Data not available N = 13 Withdrawals Discharge N = 551 N = 22 Data not available N = 45 Withdrawals 1-year follow-up complete 86% patient data available

  9. Baseline Demographics and Co-Morbidities

  10. Baseline Demographics and Co-Morbidities

  11. MitraClip Implant Rate and Number of Clips Implanted 99.6% Implant Rate N=567

  12. Post-Procedure and Discharge Results * Denominators smaller than 567 reflect missing data.

  13. Site Reported Safety Events At 30 Days * As reported by the sites

  14. Kaplan-Meier Freedom from Death 30 Days 97.4% 95.6% 96.6% 1 Year 86.4% 76.3% 81.8% p<0.05 Logistic EuroSCORE <20% (N=314) Logistic EuroSCORE ≥20% (N=253) All Patients (N=567)

  15. Site Reported Safety Events At 1 Year * As reported by the sites

  16. Mitral Regurgitation Grade* p<0.0001 0 2+ 1+ 3+ 79% MR ≤ 2+ at 1 Year 2+ 4+ 3+ 4+ N = 327 Matched Cases * As assessed by the sites

  17. NYHA Functional Class p<0.0001 I II I II III III IV IV 72% NYHA Class I or II at 1 Year N = 343 Matched Cases

  18. Quality of Life Score (MLHFQ) and 6-Minute Walk Distance MLHFQ 6MWT p<0.0001 p<0.0001 Mean improvement -13.5 points 95% CI: (-16.0, -11.0) Mean improvement 59.5 meters 95% CI: (44.5, 74.6) Baseline 1 Year Baseline 1 Year N = 264 Matched Cases N = 216 Matched Cases

  19. Summary • Patients treated in the ACCESS-EU study were elderly, symptomatic and had multiple major co-morbidities, indicating the high risk nature of this patient population. • A high device implant success and a low rate of a procedural safety events demonstrate that the MitraClip device can be performed safely in this complex patient population. • ACCESS-EU 1-year results show that the MitraClip device safely reduces MR and provides meaningful clinical benefits, including significant improvements in: • NYHA Functional Class • Quality-of-Life (MLHFQ) • Six-Minute Walk Distance

  20. Conclusion • The MitraClip procedure provides significant clinical benefits to patients with severe MR in a real world setting consistent with results in controlled clinical trials. • The MitraClip therapy therefore provides a treatment option for a patient population with an important unmet clinical need.

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