The CARILLON: Device Iteration, New Data and New Trials Steven L. Goldberg, MD Director, Cardiac Cath Lab Clinical Associate Professor of Medicine University of Washington Medical Center Chief Clinical Officer Cardiac Dimensions, Inc.

Disclosures Consultant Cardiac Dimensions – Chief Clinical Officer Stock-options (Cardiac Dimensions, Inc.) I will be speaking about Investigational Devices

CARILLON® Mitral Contour System™

Device Iteration

Twist added to improve anchor stability Modification of proximal anchor to address clinically silent wireform fractures

Device Integrity Observation Strain Reliefs, 2 Fx Proximal Eyelet, 8 Fx “Cosmetic” – no clinical implications No complications and similar efficacy as non- fracture patients 7 7

Minor device modifications Old XE2 Current XE2

New Data

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% (9-39) MR (Baseline) 2+ = 16 3+ = 29 4+ = 8 LVEDD (mm) 70 (55–81) 11 11

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% (9-39) MR (Baseline) 2+ = 16 3+ = 29 4+ = 8 LVEDD (mm) 70 (55–81) 12 12

TITAN – MR Results Absolute differences from baseline Non-Implanted Implanted 11 6 5 * *** * *** cm2 cm 13 9 7 30 31 23 34 31 25 ml % Area 12 9 7 13 9 6 34 31 25 30 31 24 *p<0.05, **p<0.01, ***p<0.001 Paired between groups comparison of absolute differences from baseline 13

Titan – LV Remodeling Results Absolute differences from baseline Non-Implanted Implanted 12 9 8 13 9 7 * ml ** cm * 34 31 25 34 31 25 10 9 6 12 9 7 cm * * ml 33 28 22 33 29 24 *p<0.05, **p<0.01, ***p<0.001 Between groups comparison of absolute differences from baseline 14

TITAN Long Term Efficacy Results Implanted Patients NYHA Class meters Baseline 1 Month 6 Months 12 Months 24 Months 36 Months Repeated measures ANOVA 15 15

New Trials

PRIME: Percutaneous Repair In functional Mitral REgurgitation TITAN II sites Clermont-Ferrand TITAN II Assessment of device modified to prevent wireform fractures PRIME: Percutaneous Repair In functional Mitral REgurgitation Initial Commercialization Experience with 5 year follow-up Germany/Italy….. Neuss Poznan Köln Frankfurt

1 year follow-up – no fracture (No fracture seen in TITAN II)

Similar quantitative echo improvements in TITAN II as TITAN Jet area/Left atrial area Regurgitant Volume N = 34 N = 9 Improved implant rate – 82%

A great acute result (PRIME) University of Leipzig (1st day with Carillon) Baseline Implant (Intraprocedural)

A rather remarkable observation Neuss, Germany Baseline Implant (Intraprocedural)

Baseline VC – 0.52 Post VC – 0.35

12 month follow-up Neuss, Germany Baseline 12 month CONFIDENTIAL

TITAN – MR Results Absolute differences from baseline Non-Implanted Implanted 11 6 5 * *** * *** cm2 cm 13 9 7 30 31 23 34 31 25 ml % Area 12 9 7 13 9 6 34 31 25 30 31 24 *p<0.05, **p<0.01, ***p<0.001 Paired between groups comparison of absolute differences from baseline 24

Conclusions Placement of the CARILLON Mitral Contour System associated with improvement in MR over year after implant, with clinical benefits seen out to 3 years This new therapy for functional MR now available for commercial implantation in selected countries (and growing), with planned registry follow-up (PRIME)

THANK YOU! CARILLON BELLS KIRKLAND, WASHINGTON