1. Endovascular Valve Edge-to-Edge REpair Study (EVEREST II) Randomized Clinical Trial: Primary Safety and Efficacy Endpoints American College of Cardiology March 14, 2010 Atlanta, GA Ted Feldman, Laura Mauri, Elyse Foster, Don Glower on behalf of the EVEREST II Investigators

2. 2 Investigational Device only in the US; Not available for sale in the US Disclosures  Research Grants – Abbott, Edwards  Consultant – Abbott, Edwards

3. 3 Investigational Device only in the US; Not available for sale in the US Perspective  >250,000 cases of significant Mitral Regurgitation diagnosed annually in the US  Current therapeutic options: Medical management –Effective in symptom management –Ineffective in treating underlying pathophysiology or disease progression Surgical Repair or Replacement (Standard of Care) –Effective yet invasive with associated morbidity –Only ~20% of patients with significant MR undergo MV surgery  Unmet need for an effective less invasive option

4. 4 Investigational Device only in the US; Not available for sale in the US Catheter-Based Mitral Valve Repair MitraClip ® System

5. 5 Investigational Device only in the US; Not available for sale in the US Clinical Experience StudyPopulationn EVEREST I (Feasibility) * Non-randomized55 EVEREST II * Pre-randomization60 EVEREST IIHigh Risk Registry78 EVEREST II (Pivotal)Randomized patients (2:1 MitraClip to Surgery) 279 184 MitraClip 95 Surgery REALISM (Continued Access)High Risk & Non High Risk266 European Experience472 Total 1,115 MitraClip Data as of 2/15/2010. *Percutaneous Mitral Valve Repair Using the Edge-to-Edge Repair: Six months Results of the EVEREST Phase I Clinical trial, JACC 2005;46:2134-2140. Percutaneous Mitral Repair with the MitraClip System: Safety and Midterm Durability in the Initial EVEREST Cohort, JACC 2009; 54:686-694.

6. 6 Investigational Device only in the US; Not available for sale in the US EVEREST II Randomized Clinical Trial Study Design 279 Patients enrolled at 37 sites Randomized 2:1 Echocardiography Core Lab and Clinical Follow-Up: Baseline, 30 days, 6 months, 1 year, 18 months, and annually through 5 years Control Group Surgical Repair or Replacement N=95 Significant MR (3+-4+) Specific Anatomical Criteria Device Group MitraClip System N=184

7. 7 Investigational Device only in the US; Not available for sale in the US EVEREST II Randomized Clinical Trial Study Organization Principal Investigators:Ted Feldman, MD Evanston NorthShore University HealthSystem Donald Glower, MD Duke University Medical Center Academic Research Organization:Laura Mauri, MD Harvard Clinical Research Institute Data Safety Monitoring Board:Richard Shemin, MD University of California, Los Angeles Clinical Events Committee:Don Cutlip, MD Harvard Clinical Research Institute Echocardiography Core Lab: Elyse Foster, MD University of California, San Francisco Sponsor:Abbott Vascular Structural Heart (Evalve) Menlo Park, CA

8. 8 Investigational Device only in the US; Not available for sale in the US EVEREST Clinical Investigators T Feldman, J Alexander, R Curran, E Chedrawy, S Smart, M Lampert NorthShore University HealthSystem, Evanston, IL A Wang, D Glower, J Jollis Duke University, Durham, NC T Byrne, P Tibi, HK Fang, JM MorganBanner Good Samaritan Medical Center, Phoenix, AZ R Quesada, J Lamelas, N Moreno, R MachadoBaptist Hospital of Miami, Miami, FL P Grayburn, B Hamman, R Hebeler, M Mack, W RyanBaylor University Medical Center, Dallas, TX A Eisenhauer, M Davidson, L Cohn, J WuBrigham and Women’s Hospital, Boston, MA J Hermiller, D Heimansohn, K Allen, D SegarThe Care Group, Indianapolis, IN M Rinaldi, E Skipper, R Steigel, J Cook, G Rose Carolinas Medical Center, Charlotte, NC S Kar, G Fontana, A Trento, R Kass, W Cheng, R Siegel, K TolstrupCedars-Sinai Medical Center, Los Angeles, CA P Whitlow, T Mihaljevic, N Smidera, L Sevensson, E Roselli, L Rodriquez, W StewartThe Cleveland Clinic, Cleveland, OH H Wasserman, W Gray, A Stewart, M Williams, M Argenziano, S Homma, R Pizzarello, L Gillam Columbia University, New York, NY; Danville, CT P Block, Z Ghazzal, T Vassiliades, R Martin, J Merlino, S LerakisEmory University Hospital, Atlanta, GA B Whisenant, S Clayson, B Reid, S Horton, J OrfordLatter Day Saints Hospital, Salt Lake City, UT R Smalling, G Letsou, J Walkes, C LoghinMemorial Hermann Hospital, Houston, TX W Pedersen, V Kshettry, F Eales, T Flavin, T Kroshus, R BaeMinneapolis Heart Institute, Minneapolis, MN O Nass, D Gangahar, R Jex, R KacereNebraska Heart Institute, Lincoln, NE SC Wong, OW Isom, L Girardi, K Krieger, R Devereux, R MishraNew York Presbyterian Hospital, New York, NY J Slater, A Galloway, G Perk, I KronzonNYU Medical Center, New York, NY S Ramee, C Van Meter, P Parrino, C Lavie, Y Gilliland, VS LucasOchsner Clinic Foundation, New Orleans, LA R Kipperman, S Lucas, RM Bodenhamer, J Randolph, J WilliamsOklahoma Heart Hospital, Okalahoma City, OK R Leung, R MacArthur, J Mullen, D Ross, J ChoyRoyal Alexandra Hospital, Edmonton, AB, Canada P Kramer, B Castlemain, A Schwartz, L Crouse, V Pasnoori Shawnee Mission Medical Center, Shawnee Mission, KS A Berke, N Robinson, R Colangelo, P Damus, H Fernandez, J Taylor, N Bercow, A KatzSt. Francis Hospital, Long Island, NY M O'Donnell, M Qureshi, A Pruitt, B Kong, B McAllister, S GirardSt. Joseph’s Mercy Hospital, Ypsilanti, MI T Bajwa, D O’Hair, D Kress, K SagarSt. Luke’s Medical Center, Milwaukee, WI JT Maddux, M Sanz, S Tahta, JM Maxwell, B Berry, J KnappSt. Patrick's Hospital & Health Science Ctr, Missoula, MT W Gray, M Reisman, W Curtis, D Gartman, J Teply, D Warth, K KrabillSwedish Medical Center, Seattle, WA P Fail, K Paape, T Fudge, M Trotter, M Allam, E Feinberg, V Tedesco, D SoletTerrebonne General Medical Center, Houma, LA E Horlick, T David, M Borger, M Mezody Toronto General Hospital, Toronto, ON, Canada R Low, N Young, K Shankar, R Calhoun, W BommerUniversity of California at Davis, Sacramento, CA J Carroll, J Cleveland, R QuaifeUniversity of Colorado Health Sciences Center, Denver, CO H Herrmann, M Acker, YJ Woo, F Silvestry, S WiegersUniversity of Pennsylvania, Philadelphia, PA S Bailey, E Sako, J EriksonUniversity of Texas Health Sciences Ctr, San Antonio, TX DS Lim, I Kron, J Kern, J Dent, H GutgesellUniversity of Virginia, Charlottesville, VA E Fretz, J Ofiesh, M MannVictoria Heart Institute Foundation, Victoria BC, Canada K Kent, S Boyce. P Sears-RoganWashington Hospital Center, Washington DC J Lasala, M Moon, R Damiano, B Lindman, A Zajarias, J MadrazoWashington University Medical Center, St. Louis, MO G Hanzel, F Shannon, M Sakwa, A Abbas, M Gallagher, P MarkovitzWilliam Beaumont Hospital, Royal Oak, MI Interventional Cardiologist, Cardiac Surgeon, Echocardiologist

9. 9 Investigational Device only in the US; Not available for sale in the US EVEREST II Randomized Clinical Trial Key Inclusion/Exclusion Criteria Inclusion Candidate for MV Surgery Moderate to severe (3+) or severe (4+) MR –Symptomatic o>25% EF & LVESD ≤55mm –Asymptomatic with one or more of the following oLVEF 25-60% oLVESD ≥40mm oNew onset atrial fibrillation oPulmonary hypertension Exclusion AMI within 12 weeks Need for other cardiac surgery Renal insufficiency –Creatinine >2.5mg/dl Endocarditis Rheumatic heart disease MV anatomical exclusions –Mitral valve area <4.0cm 2 –Leaflet flail width (≥15mm) and gap (≥10mm) –Leaflet tethering/coaptation depth (>11mm) and length (<2mm) ACC/AHA Guidelines JACC 52:e1-e142, 2008

10. 10 Investigational Device only in the US; Not available for sale in the US Device (%) n=184 Control (%) n=95 P Age (mean)67.3 years65.7 years0.32 Male62.566.30.60 Congestive heart failure90.877.9<0.01 Coronary artery disease47.046.3>0.99 Myocardial infarction21.921.3>0.99 Angina31.922.20.12 Atrial fibrillation33.739.30.42 Cerebrovascular disease7.65.30.62 Peripheral vascular disease6.511.60.17 Cardiomyopathy17.914.70.61 Hypercholesterolemia61.062.80.80 Hypertension72.378.90.25 Moderate to severe renal disease3.32.10.72 Diabetes7.610.50.50 Previous cardiovascular surgery22.318.90.54 MR Severity: 3+ to 4+95.792.60.48 MR Etiology: Degenerative / Functional73 / 27 0.81 EVEREST II Randomized Clinical Trial Baseline Demographics & Co-morbidities

11. 11 Investigational Device only in the US; Not available for sale in the US EVEREST II RCT n=279 2008 STS DatabaseIsolated 1 st Elective Operation for MR* RepairReplaceHigh Volume Hospitals (>140/Yr) Age yrs (mean)68606159 ≥65 yrs58%37%45%n/a ≥75 yrs32%n/a 0% NYHA Class III or IV50%26%45%n/a CHF86%41%58%n/a Hypertension75%60%67%43% Diabetes Mellitus9%13%23%6.5% COPD / Chronic Lung Disease 15%17%29%n/a EF (mean)60%53%55%56% EVEREST II Randomized Clinical Trial Demographic Comparison *Gammie JS et al Influence of Hospital Procedural Volume on Care Process and Mortality for Patients Undergoing Elective Surgery for Mitral Regurgitation. Circ 2007;115:881-887.

12. 12 Investigational Device only in the US; Not available for sale in the US EVEREST II Randomized Clinical Trial Primary Endpoints Safety  Major Adverse Event Rate at 30 days  Per protocol cohort  Superiority hypothesis Effectiveness  Clinical Success Rate Freedom from the combined outcome of –Death –MV surgery or re-operation for MV dysfunction –MR >2+ at 12 months  Per protocol cohort  Non-inferiority hypothesis Pre-Specified MAEs Death Major Stroke Re-operation of Mitral Valve Urgent / Emergent CV Surgery Myocardial Infarction Renal Failure Deep Wound Infection Ventilation >48 hrs New Onset Permanent Atrial Fib Septicemia GI Complication Requiring Surgery All Transfusions ≥2 units

13. 13 Investigational Device only in the US; Not available for sale in the US EVEREST II Randomized Clinical Trial Additional Analyses Intention to Treat  Safety Major Adverse Event Rate at 30 days  Effectiveness Freedom from the combined outcome of death, MV surgery >90 days or re-operation for valve dysfunction >90 days post Index procedure, and MR >2+ at 12 months Clinical Benefit (per protocol cohort)  MR Severity  Left Ventricular Function  NYHA Functional Class  Quality of Life (SF-36 Survey)

14. 14 Investigational Device only in the US; Not available for sale in the US EVEREST II RCT: Patient Flow Per Protocol Cohort: Analysis of Device Performance Acute Procedural Success (APS) = MR ≤2+ at discharge 12 months n=134 98.5% Clinical Follow-up 98% Echo Follow-up 12 months n=74 94% Clinical Follow-up 92% Echo Follow-up 30 days n=136 99% Clinical Follow-up 30 days n=79 99% Clinical Follow-up Acute Procedural Success Achieved n=137 Randomized, not treated Device, n=6 Control, n=15 Treated n=178 Treated n=80 (86% MV repair) Device Group n=184 Acute Procedural Success Not Achieved n=41 Control Group n=95 Randomized Cohort n=279

15. 15 Investigational Device only in the US; Not available for sale in the US EVEREST II RCT: Patient Flow Post MitraClip Procedure 2 nd MitraClip Procedure n=3 MV Surgery Post MitraClip Procedure n=9 2 nd MitraClip Procedure n=2 No Additional Intervention n=11 MV Surgery Post MitraClip Procedure n=28 Acute Procedural Success Not Achieved n=41 Acute Procedural Success Achieved n=137 n=37 81% Follow-up 96% MR ≤2+ at 12 months

16. 16 Investigational Device only in the US; Not available for sale in the US 16 Patients randomized but not treated are included in ITT analysis EVEREST II RCT: Patient Flow Intention to Treat Cohort: Analysis of Treatment Strategy Randomized Cohort n=279 Device Group n=184 Control Group n=95 12 months n=175 92% Follow-up 30 days n=180 95% Follow-up 30 days n=94 84% Follow-up 12 months n=89 78% Follow-up

17. 17 Investigational Device only in the US; Not available for sale in the US EVEREST II RCT: Primary Endpoints Per Protocol Cohort 9.6% Device Group, n=136 Control Group, n=79 57.0% Met superiority hypothesis Pre-specified margin = 6% Observed difference = 47.4% 97.5% LCB = 34.4% 72.4% 87.8% Control Group, n=74 Device Group, n=134 Met non-inferiority hypothesis Pre-specified margin = 31% Observed difference = 15.4% 95% UCB = 25.4% Safety Major Adverse Events 30 days Effectiveness Clinical Success Rate * 12 months LCB = lower confidence bound UCB = upper confidence bound p SUP <0.0001p NI =0.0012 * Freedom from the combined outcome of death, MV surgery or re-operation for MV dysfunction, MR >2+ at 12 months

18. 18 Investigational Device only in the US; Not available for sale in the US # Patients experiencing event Device Group (n=136) Control Group (n=79) Death 0 2 (2.5%) Major Stroke 0 2 (2.5%) Re-operation of Mitral Valve 0 1 (1.3%) Urgent / Emergent CV Surgery 0 4 (5.1%) Myocardial Infarction 0 0 Renal Failure 0 0 Deep Wound Infection 0 0 Ventilation >48 hrs 0 4 (5.1%) New Onset Permanent Atrial Fib 0 0 Septicemia 0 0 GI Complication Requiring Surgery 1 (0.7%) 0 All Transfusions ≥2 units* 12 (8.8%) 42 (53.2%) TOTAL % of Patients with MAE 9.6% 57.0% p<0.0001* (95% CI 34.4%, 60.4%) EVEREST II RCT: Primary Safety Endpoint Per Protocol Cohort 30 Day MAE, non-hierarchical *p<0.0001 if include Major Bleeding only

19. 19 Investigational Device only in the US; Not available for sale in the US Additional Analyses  Intention to Treat Safety & Effectiveness  Clinical Benefit (per protocol cohort) MR Severity Left Ventricular Function NYHA Functional Class Quality of Life

20. 20 Investigational Device only in the US; Not available for sale in the US Safety Major Adverse Events 30 days Effectiveness Clinical Success Rate * 12 months EII RCT: Safety & Effectiveness Endpoints Intention to Treat Cohort Device Group, n=180 Control Group, n=94 Met superiority hypothesis Pre-specified margin =2% Observed difference = 32.9% 97.5% LCB = 20.7% Control Group, n=89 Device Group, n=175 Met non-inferiority hypothesis Pre-specified margin = 25% Observed difference = 7.3% 95% UCB = 17.8% 66.9% 74.2% 15.0% 47.9% LCB = lower confidence bound UCB = upper confidence bound p SUP <0.0001p NI =0.0005 * Freedom from the combined outcome of death, MV surgery or re-operation for MV dysfunction >90 days post Index procedure, MR >2+ at 12 months

21. 21 Investigational Device only in the US; Not available for sale in the US Device GroupControl Group EVEREST II RCT: MR Reduction Per Protocol Cohort ≤2+ n=137n=119n=80n=67 3+/4+ ≤2+ 3+/4+ 81.5% 18.5% 3+/4+ 97.0%

22. 22 Investigational Device only in the US; Not available for sale in the US EVEREST II RCT: MR Reduction Per Protocol Cohort Device GroupControl Group

23. 23 Investigational Device only in the US; Not available for sale in the US EVEREST II RCT: Left Ventricular Volume Per Protocol Cohort LVEDVLVESV Control Group n=65, matched data LVEDVLVESV Baseline12 Months Pre-specified hypothesis for statistical analysis p<0.0001 Device Group n=118, matched data LVEDV = left ventricular end diastolic volume LVESV = left ventricular end systolic volume p=0.0005 p<0.0001 p=0.0255

24. 24 Investigational Device only in the US; Not available for sale in the US EVEREST II RCT: Left Ventricular Dimension Per Protocol Cohort LVID systoleLVID diastole p<0.0001 LVID systoleLVID diastole Baseline12 Months Control Group n=65, matched data Device Group n=118, matched data LVIDd = left ventricular internal diameter, diastole LVIDs = left ventricular internal diameter, systole Pre-specified hypothesis for statistical analysis p=0.0564 p<0.0001 p=0.4785

25. 25 Investigational Device only in the US; Not available for sale in the US EVEREST II RCT: NYHA Functional Class Per Protocol Cohort 97.6% NYHA Class I/II 87.9% NYHA Class I/II n=124, Matched datan=66, Matched data I II III I II III IV III II I I Device Group Control Group Baseline 12 months p<0.0001 Hypothesis not pre-specified for statistical analysis

26. 26 Investigational Device only in the US; Not available for sale in the US EVEREST II RCT: Quality of Life, SF-36 Survey Per Protocol Cohort PCS MCS Baseline n=120, matched pairsn=64, matched pairs 30 days Device Group 30 Day Scores p<0.0001 PCS MCS PSC = Physical Component Summary MCS = Mental Component Summary Hypothesis not pre-specified for statistical analysis Control Group p<0.0001 P=0.0043 P=0.2910 12 Months 12 Month Scores n=60, matched pairsn=110, matched pairs MCS PCS Control GroupDevice Group P<0.0001 P=0.0017 P=0.0057

27. 27 Investigational Device only in the US; Not available for sale in the US  Safety & effectiveness endpoints met Safety: MAE rate at 30 days –MitraClip device patients: 9.6% –MV surgery patients: 57% Effectiveness: Clinical Success Rate at 12 months –MitraClip device patients: 72% –MV Surgery patients: 88%  Clinical benefit demonstrated for MitraClip System and MV surgery patients through 12 months –Improved LV function –Improved NYHA Functional Class –Improved Quality of Life  Surgery remains an option after the MitraClip procedure EVEREST II RCT: Summary

28. 28 Investigational Device only in the US; Not available for sale in the US The MitraClip procedure is an important therapeutic option for selected patients with significant mitral regurgitation given the demonstrated safety, effectiveness and clinical benefit. EVEREST II RCT: Conclusion