MiCardia:
               Dynamic Mitral Annuloplasty
                Device Design Concepts,
                Experimental ...
Why Degradable Stents?
                           Disclosure

                    M.Buchbinder – Scientific Advisory,
    ...
Ischemic MR
      • Ischemic Mitral Regurgitation (IMR) is seen
        in up to 20% of patients following acute
        m...
Ischemic MR
      • Following isolated annuloplasty surgery
        recurrent (>2+) MR is seen in 10-30% of
        patien...
Current technology does not cope with
                        dynamic ischemic disease
       • MITRAL
               •Res...
MiCardia Semi-Rigid Dynamic
          Annuloplasty “C” Ring (Degenerative)




                               Baseline Sha...
MiCardia Rigid Dynamic Annuloplasty
                 “D” Ring (Ischemic)




                      Baseline




          ...
The MiCardia Dynamic Ring
         •    “C” and “D” shapes available sizes 28mm through 36mm
         •    Without activat...
Intra-Operative Re-shaping
       •     Each RF wire is connected
             to the propriatary MiCardia
             RF...
Dynamic Ring - Features
      • Implants identical to
        existing technology

      • Semi-rigid metal core
        m...
Intra-Operative Reshaping
                   Early “In-Vivo” experience
      • A-P distance
        shortening by
       ...
Degenerative Ring Activation




                   Pre-Activation        Intra-Op Activation
Maurice Buchbinder, MD
Found...
Ultimate Valve
                           Repair Modality


Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
Percutaneous Reshaping
      • The implanted ring is
        accessed via transeptal
        approach.
      • Thru a Defl...
Percutaneous Animal Experience

   • A-P distance
     shortened by
     0.3-2.9mm
   • Inter-Commissural
     Distance
  ...
TransQ Device Platform

                                         • Single lead, atrial exit
                              ...
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
Transcutaneous Activation
      • Lead Exits Left
       Atrium
      • Completely
       encapsulated 40 days
      • Con...
Transcutaneous Activation

       • Full activation takes
        place within 60
        seconds.




Maurice Buchbinder,...
Transcutaneous Activation

      • No infection
      • No dehiscence
      • Full activation 60+
       days
      • 100%...
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
26 Human Implants completed
                  (June 09)




Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
First-in-Man Experience
                                   February 2008
      • 4+MR with P2 leaflet prolapse

      • Le...
First-in-Man Experience
                                    P2 prolapse




Maurice Buchbinder, MD
Foundation for Cardiova...
First-in-Man Experience
        4+MR with eccentric anterior jet




Maurice Buchbinder, MD
Foundation for Cardiovascular ...
First-in-Man Experience
           Post repair no MR acute and at discharge




Maurice Buchbinder, MD
Foundation for Card...
First-in-Man Experience
                       Ring shape at discharge




Maurice Buchbinder, MD
Foundation for Cardiovas...
Future Developments
                     2004-2008                2009-2010             2009-2011


       Mitral

       ...
Magnetic Ring
           • Magnetic drive: no motor
           • AP + or AP - models
           • Infinitely adjustable
  ...
Conclusion
      • From this early clinical experience the MiCardia Dynamic
        Annuloplasty Ring appears to be a prom...
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Dynamic Mitral Annuloplasty Device Design Concepts, Experimental Insights and First-in-Man

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Dynamic Mitral Annuloplasty Device Design Concepts, Experimental Insights and First-in-Man

  1. 1. MiCardia: Dynamic Mitral Annuloplasty Device Design Concepts, Experimental Insights and First-in-Man Maurice Buchbinder, MD Foundation for Cardiovascular Medicine La Jolla, CA Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  2. 2. Why Degradable Stents? Disclosure M.Buchbinder – Scientific Advisory, Board Member Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  3. 3. Ischemic MR • Ischemic Mitral Regurgitation (IMR) is seen in up to 20% of patients following acute myocardial infraction. (Hickey; Circulation 1988;78:151- 159, Lamas; Circulation 1997; 96:827-833) • 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. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  4. 4. 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.) Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  5. 5. Current technology does not cope with dynamic ischemic disease • MITRAL •Residual post-op Edwards Physio occurrence of 6- 10% •6m recurrence of 15%-25% Medtronic Duran •3 Yr, recurrence of 30% to 50% • TRICUSPID •“Upon Discharge” recurrence of 25% SJM Tailor to 30% •Directly contributes to the onset of HF ATS Simulus when untreated Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  6. 6. MiCardia Semi-Rigid Dynamic Annuloplasty “C” Ring (Degenerative) Baseline Shape (Implanted) Transparent = Baseline Red = Post Activation Shape Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  7. 7. MiCardia Rigid Dynamic Annuloplasty “D” Ring (Ischemic) Baseline MiCardia Dynamic Ring Transparent = Baseline Red = Activated Shape Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  8. 8. The MiCardia Dynamic Ring • “C” and “D” shapes available sizes 28mm through 36mm • Without activation functions as a “standard” ring • Pre-attached electrodes used for activation make the ring Dynamic Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  9. 9. Intra-Operative Re-shaping • Each RF wire is connected to the propriatary MiCardia RF generator. P1 P3 • Following implantation and pending degree of residual P2 MR ,Wires are activated as to re-shape the ring in vivo • Echocardiography confirms effectiveness of activation during and post re-shaping Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  10. 10. Dynamic Ring - Features • Implants identical to existing technology • Semi-rigid metal core maintains its shape. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  11. 11. Intra-Operative Reshaping Early “In-Vivo” experience • A-P distance shortening by 0.5-3.0mm • Inter-Commissural distance contracted by 1.0-3.5mm • No heat damage to the surrounding Postero-Medial commissure activation tissue Courtesy Dr. Alex Marmureanu Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  12. 12. Degenerative Ring Activation Pre-Activation Intra-Op Activation Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  13. 13. Ultimate Valve Repair Modality Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  14. 14. Percutaneous Reshaping • The implanted ring is accessed via transeptal approach. • Thru a Deflectable guide catheter system for optimal positioning • An Expandable basket with built in RF electrodes is used to activate the ring upon contact in multiple zones. • On line echocardiography confirms effectiveness of activation during and after re- shaping Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  15. 15. Percutaneous Animal Experience • A-P distance shortened by 0.3-2.9mm • Inter-Commissural Distance contracted by 1.2- 3.6mm Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  16. 16. TransQ Device Platform • Single lead, atrial exit • No flow interference • Subcutaneous “pocket“ deployment of lead • Simple outpatient activation 30 Minute Outpatient Adjustment • Activate days, weeks or By Interventional months after the initial Cardiologist procedure to correct recurrence Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  17. 17. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  18. 18. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  19. 19. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  20. 20. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  21. 21. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  22. 22. Transcutaneous Activation • Lead Exits Left Atrium • Completely encapsulated 40 days • Connects to MiCardia RF Generator • Allows for Delayed Activation Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  23. 23. Transcutaneous Activation • Full activation takes place within 60 seconds. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  24. 24. Transcutaneous Activation • No infection • No dehiscence • Full activation 60+ days • 100% in-growth • 40 and 60 day testing Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  25. 25. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  26. 26. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  27. 27. 26 Human Implants completed (June 09) Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  28. 28. First-in-Man Experience February 2008 • 4+MR with P2 leaflet prolapse • Leaflet resection with implantation of a 28mm D+ ring. • Reduced to trace MR Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  29. 29. First-in-Man Experience P2 prolapse Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  30. 30. First-in-Man Experience 4+MR with eccentric anterior jet Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  31. 31. First-in-Man Experience Post repair no MR acute and at discharge Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  32. 32. First-in-Man Experience Ring shape at discharge Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  33. 33. Future Developments 2004-2008 2009-2010 2009-2011 Mitral Mitral Shape Magnetic Memory Tricuspid Percutaneous External Tricuspid Intra-Operative Trans‐Q Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  34. 34. Magnetic Ring • Magnetic drive: no motor • AP + or AP - models • Infinitely adjustable • Can be titrated • Reversible • Multiple activations • Percutaneous activation via R. Heart Access (16Fr) • External via TEE access Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  35. 35. Conclusion • From this early clinical experience the MiCardia Dynamic Annuloplasty Ring appears to be a promising device for treatment of Mitral regurgitation. • The In-Vivo adjustable feature may be an extremely valuable tool for optimization of surgical results • Further percutaneous adjustments in ring geometry in the healing phase could be a compelling advantage for its use . Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

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