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1 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 European Society of Cardiology Congress 2012 Munich,

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Presentation on theme: "1 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 European Society of Cardiology Congress 2012 Munich,"— Presentation transcript:

1 1 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 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 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

2 2 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 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. Affiliation/Financial RelationshipCompany Consulting Fees/HonorariaAbbott Vascular Abiomed AstraZeneca Edwards Lifesciences Servier St. Jude Medical

3 3 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 Transcatheter Mitral Valve Repair MitraClip ® System

4 4 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 MitraClip Therapy Worldwide 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 5 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 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 6 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 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 7 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 Enrolling Centers: ACCESS EU Phase I 14 centers have enrolled MitraClip patients Enrolling CenterPrincipal Investigator UKE, HamburgDr. Baldus, Dr. Treede Universitätsmedizin, GöttingenDr. Schillinger Asklepios Klinik St. Georg, HamburgDr. Schäfer Krankenhaus Bernau, BrandenburgDr. Butter Deutsches Herzzentrum, MunichDr. Hausleiter Ospedale Ferrarato, CataniaDr. Ussia San Raffaele, MilanDr. Maisano CardioVasculares Centrum St. Katharinen, FrankfurtDr. Sievert Rigshospital, CopenhagenDr. Soendergaard, Dr. Franzen Segeberger Kliniken GmbH, Bad SegebergDr. Richardt Cardiocentro Ticino, LuganoDr. Mocceti Medizinische Hochschule, HannoverDr. Klein Universitätsklinikum, AachenDr. Hoffmann Herzzentrum, LeipzigDr. Thiele

8 8 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 Patient Accountability MitraClip Patients Treated in ACCESS-EU N = 567 N = 22 Data not available N = 45 Withdrawals 1-year follow-up complete 86% patient data available Discharge N = 551 N = 3 Data not available N = 13 Withdrawals 1 Year Follow-up N = 487

9 9 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 Baseline Demographics and Co-Morbidities Demographics and Co-morbidities EVEREST II RCT Device Patients N=178 EVEREST II High Surgical Risk Cohort N=211 ACCESS EU – MitraClip Patients N=567 Age (mean ± SD), years67 ± 1376 ± 1074 ± 10 Logistic EuroSCORE, (%) Mean ± SDNA 23 ± 18 Logistic EuroSCORE ≥ 20%, (%)NA 45 STS Mortality Risk, (%) Mean ± SD5 ± 412 ± 8NA STS Mortality Risk ≥ 12%, (%)648NA Male Gender, (%)646164 Coronary Artery Disease, (%)478163 Previous Cardiovascular Surgery, (%)235837 Myocardial Infarction, (%)224932 Cerebrovascular Disease, (%)82113 Moderate to Severe Renal Failure, (%)33142 Atrial Fibrillation, (%)336468 NYHA Functional Class III or IV, (%)508685

10 10 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 Baseline Demographics and Co-Morbidities Demographics and Co-morbidities EVEREST II RCT Device Patients N=178 EVEREST II High Surgical Risk Cohort N=211 ACCESS EU – MitraClip Patients N=567 Mitral Regurgitation Grade ≥ 3+, (%)968698 Ejection Fraction < 40%, (%)62853 Functional MR, (%)277177 IschemicNA 42 Non-ischemicNA 58 Degenerative MR, (%)732923

11 11 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 MitraClip Implant Rate and Number of Clips Implanted 99.6% Implant Rate N=567

12 12 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 Post-Procedure and Discharge Results Post-Procedural and Discharge Results ACCESS EU – MitraClip Patients N=567 * Post-procedural, (median) ICU/CCU duration, (days)1.0 Length of hospital stay, (days)6.0 Discharge to, (%) Home with or without home health care79.6% (448/563) Skilled nursing facility / Hospital17.1% (96/563) Nursing home1.4% (8/563) Died prior to discharge2.0% (11/563) * Denominators smaller than 567 reflect missing data.

13 13 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 Site Reported Safety Events At 30 Days 1-Year Events* All Patients N=567 Logistic EuroSCORE ≥20% N=253 Logistic EuroSCORE <20% N=314 p-value Death19 (3.4%)11 (4.3%)8 (2.5%)ns Stroke4 (0.7%)3 (1.2%)1 (0.3%)ns Myocardial Infarction 4 (0.7%)2 (0.8%)2 (0.6%)ns Renal Failure27 (4.8%)16 (6.3%)11 (3.5%)ns Respiratory Failure4 (0.7%)3 (1.2%)1 (0.3%)ns Need for Resuscitation 10 (1.8%)7 (2.8%)3 (1.0%)ns Cardiac Tamponade6 (1.1%)3 (1.2%)3 (1.0%)ns Bleeding Complications 22 (3.9%)12 (4.7%)10 (3.2%)ns * As reported by the sites

14 14 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 Kaplan-Meier Freedom from Death At Risk0 Day30 Days180 Days360 Days All Patients567534475415 Logistic EuroSCORE <20%314296264235 Logistic EuroSCORE ≥20%253238211180 30 Days 97.4% 95.6% 96.6% 1 Year 86.4% 76.3% 81.8% Logistic EuroSCORE <20% (N=314) Logistic EuroSCORE ≥20% (N=253) All Patients (N=567) p<0.05

15 15 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 Site Reported Safety Events At 1 Year 1-Year Events* All Patients N=567 Logistic EuroSCORE ≥20% N=253 Logistic EuroSCORE <20% N=314 p-value Death98 (17.3%)58 (22.9%)40 (12.7%)<0.05 Stroke6 (1.1%)4 (1.6%)2 (0.6%)ns Myocardial Infarction 8 (1.4%)5 (2.0%)3 (1.0%)ns Renal Failure49 (8.6%)29 (11.5%)20 (6.4%)<0.05 Respiratory Failure5 (0.9%)4 (1.6%)1 (0.3%)ns Need for Resuscitation 12 (2.1%)9 (3.6%)3 (1.0%)<0.05 Cardiac Tamponade7 (1.2%)4 (1.6%)3 (1.0%)ns Bleeding Complications 27 (4.8%)16 (6.3%)11 (3.5%)ns * As reported by the sites

16 16 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 Mitral Regurgitation Grade * * As assessed by the sites N = 327 Matched Cases 79% MR ≤ 2+ at 1 Year 3+ 4+ 3+ 2+ 1+ 0 2+ 4+ p<0.0001

17 17 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 NYHA Functional Class 72% NYHA Class I or II at 1 Year N = 343 Matched Cases II III IV II III IV I I p<0.0001

18 18 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012 Quality of Life Score (MLHFQ) and 6-Minute Walk Distance Baseline1 Year N = 264 Matched Cases Mean improvement -13.5 points 95% CI: (-16.0, -11.0 ) p<0.0001 MLHFQ Baseline1 Year p<0.0001 N = 216 Matched Cases Mean improvement 59.5 meters 95% CI: (44.5, 74.6) 6MWT

19 19 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012  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 Summary

20 20 Investigational Device only in the U.S. Not available for sale in the U.S. ACCESS EU – ESC 2012  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. Conclusion

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