1. 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.

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

3. CARILLON® Mitral Contour System™

4. Device Iteration

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

6. 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

7. Minor device modifications
Old XE2
Current XE2

8. New Data

10. 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

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

12. TITAN – MR Results Absolute differences from baseline
Non-Implanted
Implanted *
*** *
***
cm2 cm ml
% Area
*p<0.05, **p<0.01, ***p<0.001
Paired between groups comparison of absolute differences from baseline 13

13. Titan – LV Remodeling Results Absolute differences from baseline
Non-Implanted
Implanted * ml ** cm * cm * * ml
*p<0.05, **p<0.01, ***p<0.001
Between groups comparison of absolute differences from baseline 14

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

15. New Trials

16. 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

17. 1 year follow-up – no fracture (No fracture seen in TITAN II)

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

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

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

21. Baseline VC – 0.52
Post VC – 0.35

22. 12 month follow-up Neuss, Germany
Baseline
12 month
CONFIDENTIAL

23. TITAN – MR Results Absolute differences from baseline
Non-Implanted
Implanted *
*** *
***
cm2 cm ml
% Area
*p<0.05, **p<0.01, ***p<0.001
Paired between groups comparison of absolute differences from baseline 24

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)

25. THANK YOU!
CARILLON BELLS
KIRKLAND, WASHINGTON