1. 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.

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

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

4. Coronary sinus as avenue for alteration of mitral valve shape

5. CARILLON® Mitral Contour System™

7. AMADEUS study

8. 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
LVEF < 40%; LVEDD > 55 mm
NYHA Class II – IV; minute walk 150 – 450 m
Stable on heart failure meds
make better 2 slides, letters are too small

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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 )
27% (MR )
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:
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:
Abraham WT. Circulation. 2004;110:
Device Embolization
0% (0/53)
Surgery or PCI Related to the Device
13% (Evalve data)
Foster E, et al. Am J Cardiol 2007; 100:
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

15. 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

16. Chronic MR Reduction
Quantitative MR
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

17. Baseline NYHA Class III 6 MWT 395 m 12 month NYHA Class I 6 MWT 600 m

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

19. 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

20. 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

21. 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

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

23. 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

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

25. Loss of mechanical integrity not functional integrity
LOI (+) Baseline
LOI (-) Baseline
LOI (+)
6-month
LOI (-)
6- month
MR grade
LVEDD (mm) EF
28+7
30+9
32+12
33+8
LA diam (mm)
NYHA
KCCQ
40+20
44+18
48+24
70+21
6MWT (m)
294+85
305+72

26. That’s All folks!!!