1. Mitralign Program Update
Lutz Buellesfeld MD
FSCAI FESC
Department of Cardiology
Bern University Hospital
Switzerland

2. Lutz Buellesfeld, MD Consulting: Mitralign Medtronic CoreValve
Edwards Lifesciences, LLC
Abbott Vascular

3. Mitralign Direct Annuloplasty
Percutaneous Annuloplasty
2 pairs of surgical pledgets delivered retrograde to posterior mitral annulus
Pair distance of mm
Pledgets are plicated (pulled together) P1 P3 P2
Pledgets rapidly encapsulate into the annulus
Open for future repair or replacement
Customized therapy
Potential for customizing number, location and plication distance to match MR and heart size
Plicated Pledget Pairs P1 P3 P2
Post-procedure 3D TEE 4

4. The Mitralign Procedure Approximating a Kay Annuloplasty
Percutaneous Repair:
Plicated pledget pair
Surgical Repair:
Kay-Wooler Annuloplasty (1962) P1 P3 P2 P1 P3 P2
Completed repair

5. Mitralign Procedure Steps
Wire Delivery
Pledget Delivery
Plication & Lock 6

6. Mitralign Implant Pair of pledgeted polyester sutures and a stainless steel lock

7. Mitralign System Components
Guide catheter
Crossing Wire
Translation (Bident) Catheter
Pledget Delivery Catheter
Plication, Lock Catheter

8. Mitralign Procedure
Pledget Delivery Catheter crossing the annulus

9. Mitralign Procedure
Pledget Delivery Catheter crossing the annulus

10. Mitralign Procedure
Plicate and Lock-Catheter allows for suture tensioning, lock advancement, plication and lock deployment 11

11. Mitralign Procedure
Deployed Lock and Cutting after Successful Plication

12. Mitralign Procedure
Final

13. 3D TEE 21 mm bident in 6.3 cm LVIDd ventricle Pre-Procedure (3+)
Post-Procedure (~Trace)

14. 2D TEE
4.8 cm LVIDd
Pre-Procedure
Post-Procedure

15. Feasibility Study Design and Patient Population
Design: Prospective, single-arm, multicenter, safety and feasibility study
Patient Population: Symptomatic Patients with Functional Mitral Regurgitation
Time points: Baseline, discharge, 30 day, 6 month, months
Enrollment: 26 of 36 patients completed
Study sites:
CAUTION: Investigational Device Only. Not approved for sale in the United States

16. Results: Interim Echo Data Analysis MR Patients with Reduction of MR and Two Pairs Implanted
Grade of MR
Pre d d d

17. Results: Interim Echo Data Analysis
LV Dimensions
Baseline
30 D 6M
12M
Baseline
30 D 6M
12M
Baseline
30 D 6M
12M
Baseline
30 D 6M
12M
6 month timepoint n=10, 12-month timepoint n=5

18. Mitralign Regulatory Status
Feasibility Study
Expanded Use Study
CE Mark
CE Marking Strategy:
Target enrollment completion: Q2 2013
US Strategy:
Feasibility Study commencement: Targeted 2013 + =

19. Conclusions
Mitralign annuloplasty with the new BIDENT System is a safe and feasible procedure
Mitralign annuloplasty has the potential to reduce FMR, inducing a reverse LV remodeling and improving clinical symptoms
Early results are promising and further studies are ongoing / in planning to demonstrate the efficacy of this approach

20. Thank you