1. Dynamic Mitral Valve Ring Annuloplasty: Micardia Concept
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
La Jolla, CA

2. Maurice Buchbinder, MD DISCLOSURES Honoraria
Boston Scientific Corporation, Cordis, a Johnson & Johnson company, Abbott Vascular

3. Why Degradable Stents? Disclosure
Speaker’s name: Maurice Buchbinder, MD
 I have the following potential conflicts of interest to report: Micardia Inc
 Consulting
 Employment in industry
 Stockholder of a healthcare company
 Scientific Advisory, Board Member
 I do not have any potential conflict of interest

4. Ischemic MR
Ischemic Mitral Regurgitation (IMR) is seen in up to 20% of patients following acute myocardial infraction. (Hickey; Circulation 1988;78: , Lamas; Circulation 1997; 96: )
Treatment of IMR includes medical therapy and in severe cases surgical repair with an undersized annuloplasty ring to reduce the size of the mitral annulus and improve leaflet coaptation.

5. Ischemic MR
Following isolated annuloplasty surgery recurrent (>2+) MR is seen in 10-30% of patients (McGee; J. Thorac Cardiovasc Surg 2004;128:916-24)
Recurrent MR appears to be commonly seen within the first year following surgery and remains relatively stable thereafter (McGee; J. Thorac Cardiovasc Surg 2004;128:916-24)
Unlike in dilated cardiomyopathy IMR is associated with asymmetric deformation of the annulus (Kwan; Circulation. 2003;107:1135.)

6. Current technology does not cope with dynamic ischemic disease
Residual post-op occurrence 6-10%
6 month, recurrence %-25%
3 Years, recurrence 30% to 50%
Edwards Physio
Medtronic Duran
SJM Tailor
ATS Simulus

7. MiCardia Semi-Rigid Dynamic Annuloplasty “C” Ring (Degenerative)
Baseline Shape (Implanted)
Transparent = Baseline
Red = Post Activation Shape

8. MiCardia Rigid Dynamic Annuloplasty “D” Ring (Ischemic)
Baseline
MiCardia Dynamic Ring
Transparent = Baseline
Red = Activated Shape

9. The MiCardia Dynamic Ring
Available in “C” and “D” shape sizes 28mm through 36mm
Without activation functions as a “standard” ring
Pre-attached electrodes used for activation make the ring Dynamic

10. Intra-Operative Re-shaping
Each RF wire is connected to the propriatary MiCardia RF generator.
Following implantation,Wires are activated as needed to re-shape the ring in vivo
Echocardiography confirms effectiveness of activation during and post re-shaping P1 P3 P2

11. Dynamic Ring - Features
Implants identical to existing technology
Semi-rigid metal core maintains its shape.

12. Dynamic Ring - Activation
Can be reshaped intra-operatively by the operating Surgeon
Or at a later date upon recurrence of MR using percutaneous techniques.

13. Intra-Operative Reshaping Pre-clinical “In-Vivo” experience

14. Intra-Operative Reshaping Pre-clinical “In-Vivo” experience
A-P distance shortening by mm
Inter-Commissural distance contracted by mm
No heat damage to the surrounding tissue
Postero-Medial commissure activation
Courtesy Dr. Alex Marmureanu

15. Ring Activation
Pre-Activation
Intra-Op Activation

16. Ultimate Valve Repair Modality

17. Percutaneous Reshaping: Sub-Q Device Platform
Single lead, atrial exit
• No flow interference
• Subcutaneous “pocket“ deployment of lead
• Simple outpatient activation
Activate days, weeks or months after the initial procedure to correct recurrence

18. Percutaneous Reshaping: Sub-Q Device Platform @140 days

19. Percutaneous Reshaping: Sub-Q Device Platform @140 days

20. Percutaneous Reshaping: Sub-Q Device Platform @140 days

21. Percutaneous Reshaping: Sub-Q Device Platform @140 days

22. Post-Activation
PRE-Activation

23. Percutaneous Reshaping: Sub-Q Device Platform @140 days
Full activation within 60 seconds

24. 140 days post implant

25. Percutaneous Reshaping: Sub-Q Device Platform @140 days
No infection
No dehiscence
Full 140 days, despite 100% in-growth

26. Human Experience

27. 39 Human Implants Completed 34 DYANA study patients treated in Europe and 5 in the US
Site
Implants
Activations
University Hospital of Homburg 7 4
Leipzig University Heart Center 11 1
Sana Herzchirurgie, Stuttgart 8 2
University Hospital, Keil
William Beaumont Hospital 5
N/A

28. TTE 2D pre-procedure Bi-leaflet Prolapse

29. TTE 4-chamber Pre-procedure

30. TTE 4-chamber post ring implant prior to activation

31. TTE 2-chamber post ring implant prior to activation

32. RF connecting cable in place

33. TEE 3-chamber Post-activation

34. TTE apical 4-chamber prior to discharge

35. PRE- Procedure TTE
Post-Procedure TTE

36. 6-Month F/U, TTE 4-chamber

37. Conclusion
From this early clinical experience the MiCardia Dynamic Annuloplasty Ring appears to be a promising device for the surgical treatment of Mitral regurgitation.
The In-Vivo adjustable feature may be an extremely valuable tool for optimization of surgical results
Further minimally invasive adjustments in ring geometry in the healing phase could be a compelling advantage for its use .
Clinical studies are ongoing.