Percutaneous Treatment for Functional Mitral Regurgitation Using The CARILLON ® Mitral Contour System™ Steven L. Goldberg, MD Director, Cardiac Cath Lab University of Washington Medical Center Seattle, Washington Chief Clinical Officer, Cardiac Dimensions, Inc.

Disclosures Part-time salaried employee of Cardiac Dimensions, Inc. Stock-options (Cardiac Dimensions, Inc.)

Prevalence of FMR by echo 3-4+ Patel, Blondheim 2-4+ Koelling, Cioffi

Coronary sinus as avenue for alteration of mitral valve shape

CARILLON® Mitral Contour System™

AMADEUS study

TITAN Trial Design (1) Objective: Prospectively evaluate the safety and efficacy of the CARILLON® Mitral Contour System™ XE2 in heart failure patients with FMR Study Design: Patients in whom device was recaptured were followed for 12 months as non-randomized, non-blinded controls Inclusion Criteria: Dilated ischemic or non-ischemic cardiomyopathy FMR 2+ - 4+ LVEF < 40%; LVEDD > 55 mm NYHA Class II – IV; 6 minute walk 150 – 450 m Stable on heart failure meds make better 2 slides, letters are too small

Trial Design (2) Safety Endpoint: 30 day rate of Major Adverse Events Efficacy Endpoints: Quantitative Assessment of FMR Exercise Tolerance: Six minute walk distance Quality of Life: Kansas City Cardiomyopathy Questionnaire make better 2 slides, letters are too small 13

TITAN™ Investigators Städtische Kliniken Neuss, Germany Prof. Dr. med. Michael Haude Cardiac & Rehabilitation Hospital Kowanówko, Poland Prof. Dr. med. Tomasz Siminiak La Clinique Pasteur Toulouse, France Dr. Jean Fajadet Universität zu Köln, Köln, Germany Prof. Dr. med. Uta Hoppe John Paul II Hospital Krakow, Poland Prof. Dr. med. Jerzy Sadowski University Hospital Clermont-Ferrand, France Dr. Janusz Lipiecki 14

TITAN™ Patient Enrollment Enrolled N=65 Screen Failure N=12 CAD requiring intervention Inadequate Vein Size Patients Attempted (Intent to Treat Population) N=53 Please add not implanted n=17 (32%), please add absolute numbers for insufficient MR reduction and coronary compromise Implanted N=36 (68%) Not Implanted N=17 Insufficient MR Reduction Coronary Compromise CAUTION: Investigational Device. For Investigational Use Only. 15

Baseline Demographics Intent to Treat Population (n=53) TITAN™ Trial Age (yrs) 62.0 (24-79) Gender M = 77% (41) F = 23% (12) Ischemic Non-Ischemic 62% 38% NYHA Class II - 1 III - 50 IV - 2 EF 28.4% (9-39) MR (Baseline) 2+ = 16 3+ = 29 4+ = 8 LVEDD (mm) 69.6 (55–81) please add a two columns for baseline demographics of implanted and non-implanted pts since the focus of this abstract is the comparison of implanted and non implanted pts CAUTION: Investigational Device. For Investigational Use Only. 16 16

Major Adverse Events 30-days post procedure TITAN™ Modified Intention to Treat Analysis Event Incidence Death 1.9% (1/53) Myocardial Infarction 0.0% (0/53) Cardiac Perforation Requiring Intervention Device Embolization Surgery or PCI Related to the Device MAE Rate please add a two columns for 30-days results of implanted and non-implanted pts since the focus of this abstract is the comparison of implanted and non implanted pts CEC adjudicated data CAUTION: Investigational Device. For Investigational Use Only. 17 17

Major Adverse Events Long-term (180 day) safety profile TITAN™ to date Modified Intention to Treat Analysis, CEC Adjudicated Event MAE Incidence Literature Rate Device Related Death Early Late 1.9% (1/53) 15.1% (8/53) 0% 16% (MR 1+ - 2+) 27% (MR 3+ - 4+) Trichon BH, et al. Am J Cardiol 2003; 91:538 MI Early 0% (0/53) 5 – 30% acute incidence Saucedo JF, et al. J.A.C.C. 2000; 35:1134-1141 7% annual incidence Boden WE, et al. N.E.J.M 2007; 356:1-14 Cardiac Perforation 1.1 – 1.4% Bristow MR, et al. N.E.J.M. 2004; 350:2140-2150 Abraham WT. Circulation. 2004;110:2864-2868 Device Embolization 0% (0/53) Surgery or PCI Related to the Device 13% (Evalve data) Foster E, et al. Am J Cardiol 2007; 100:1577-1583 MAE Rate 17% (9/53) please add a two columns for 180-days results of implanted and non-implanted pts since the focus of this abstract is the comparison of implanted and non implanted pts 19 19

Chronic Observations MAEs Death – CVA, 306 days post implant MI – NSTEMI, 224 days post implant Occasional loss of anchor wire integrity Safety maintained: No association with adverse events Efficacy maintained: Clinical improvement observed through 12 months Coronary artery management Coronary arteries were either not crossed, or could be managed with recapture / reposition feature in 85% of cases No device related MI’s MAEs Death – CVA, 306 days post implant MI – NSTEMI, 224 days post implant Occasional loss of anchor wire integrity Safety maintained: No association with adverse events Efficacy maintained: Clinical improvement observed through 12 months Coronary artery management Coronary arteries were either not crossed, or could be managed with recapture / reposition feature in 85% of cases No device related MI’s this slide can be deleted since it has confusing information with the previous slide (no. of deaths, MI definition etc). Only the management of coronary artery crossing is new, perhaps make a slide with more detailed infos based on the TCT presentation

Chronic MR Reduction Quantitative MR Measures @ Baseline (n=36), One (n=34), & Six (n=21) Months P<0.001 P<0.05 cm cm2 Overall 35% reduction in quantitative MR parameters P<0.05 Don´t we have echo data for the implanted and non implanted pts seperately? Why only 34 pts at 1 month and 21 pts at 6 months? The number of pts who died is lower than the number of lost pts with echo? Are these echo core lab data? P<0.01 ml % Area Baseline 1 Month 6 Months CAUTION: Investigational Device. For Investigational Use Only. 21

Baseline NYHA Class III 6 MWT 395 m 12 month NYHA Class I 6 MWT 600 m 601-105

Reverse Remodeling P = 0.007 P = 0.02 mm mm P = 0.07 P = 0.0027 ml ml N= 21 patients

Non-Implanted Patients Baseline Demographics TITAN – Implanted patients vs. Non-implanted patients Implanted Patients N=36 Non-Implanted Patients N=17 Age (yrs) 62.4 (29-80) 62.6 (24-80) Gender M = 75% (27) F = 25% (9) M = 82% (14) F = 18% (3) History of CAD 61% 65% Ischemic Non-Ischemic 66% 34% 53% 47% NYHA Class II - 0 % III – 94% IV – 6% II - 6% IV – 0% EF 29.2% (12-40) 25.4% (10-37) MR Grade 2+ = 12 3+ = 21 4+ = 3 2+ = 4 3+ = 8 4+ = 5 LVEDD (mm) 67.1 (53–87) 65.0 (56-76) Confidential 26 26

NYHA Classification Non-Implanted Patients Non-randomized; Non-blinded control Implanted Patients P < 0.001 Why are only data of 23 and 7 pts reported? Please add standard deviation or confidence limits of the measurements n=23 n=7 Baseline 1 Month 6 Months CAUTION: Investigational Device. For Investigational Use Only. 27 27

Six Minute Walk Test Meters Non-Implanted Patients Implanted Patients Non-randomized; Non-blinded Control Implanted Patients P < 0.01 Meters Why are only data of 23 and 7 pts reported? Please add standard deviation or confidence limits of the measurements n=23 n=7 Baseline 1 Month 6 Months CAUTION: Investigational Device. For Investigational Use Only. 28 28 28

Titan – MR Results cm2 cm ml % Area Non-Implanted Implanted 29

Summary Reduction of FMR with the coronary sinus based CARILLON Mitral Contour System is feasible and has a 1.7% MAE at 30 days Mean reduction in MR of 35% by independent echo parameters Significant and sustained improvement of 1 NYHA class, 6 minute walk test and quality of life assessments at 1 and 6 months in the intervention group Please focus the summary on the topic of the abstract which is sionafety and efficacy of the Carillon device compared to patients without successful implantation

Thank you! Steven L. Goldberg, MD Director, Cardiac Cath Lab University of Washington Medical Center Seattle, Washington Chief Clinical Officer, Cardiac Dimensions, Inc.

Loss of mechanical integrity not functional integrity LOI (+) Baseline LOI (-) Baseline LOI (+) 6-month LOI (-) 6- month MR grade 2.5+0.8 2.9+0.5 1.2+1.2 1.8+1.0 LVEDD (mm) 6.8+0.9 6.7+0.8 6.6+0.9 6.7+0.9 EF 28+7 30+9 32+12 33+8 LA diam (mm) 4.7+0.6 4.7+0.8 4.3+0.4 4.5+0.8 NYHA 3.1+0.4 3.0+0.2 2.3+0.5 2.0+0.7 KCCQ 40+20 44+18 48+24 70+21 6MWT (m) 294+85 305+72 441+200 447+225

That’s All folks!!!