1. Update on PFO stents Mark Reisman, M.D., F.A.C.C.
Director, Cardiovascular Research & Education
Swedish Heart & Vascular Institute
Swedish Medical Center
Seattle, WA

2. DISCLOSURES Mark Reisman, MD Grants/Contracted Research
Coherex Medical, Inc., NMT Medical, Inc.
Ownership Interest (Stocks, Stock Options or Other Ownership Interest)
CoAptus Medical Corporation

5. Goals of Closure Immediate in Lab Minimal residual shunt
Minimal material-specifically left side
Nothing left behind
Low chance of complications:…embolization, malapposition, thrombosis, erosion
No late “opening” of shunt

6. Challenges It is not a hole Tremendous variation in anatomy
Tunnel length
Septum primum excursion
Size of opening
Fenestrations
Septation of the septum
Thick septum secundum

7. Location, location, location

8. Methods of approach Discs Folding Wire loop Independent nitinol mesh
Sutures
Clips
Sealing-radiofrequency
Intratunnel devices
Each has challenges, disadvantages and advantages

9. Device sizing

10. Balloon through the PFO (Left side)

11. Clamshell devices

12. Atrial septal aneurysm
PFO w/ ASA**

13. The tunnel and the clamshell devices

14. Arm exteriorized from the left septum

15. It’s the tunnel………….

16. New Concept: In-tunnel Devices
left atrial view
The in- tunnel advanteges are: minimal distortion of the native anatomy and minimal foreign material in the atria

17. intratunnel devices Excellent solution Minimal material exposed
Would require some overlap
Appropriate sizing.

18. How does the FlatStent™ EF work?.
Lateral expansion by the FlatStent creates apposition between septum primum and septum secundum
These images illustrate the mechanism of action of the device, and how it looks at 30 days of healing in a porcine animal. 18

19. The FlatStent™ EF PFO Closure System.
Amplatzer on LA & RA septum
FlatStent in PFO tunnel
These TEE images demonstrate exposed surface another way. 19

20. Tunnel Morphology Funtional tunnel length
Type I
Type II
Type III
This slide and diagrams illustrate tunnel types, with special emphasis that in tunnels of 4mm or longer length, the device works most optimally. In tunnels less than 4mm, the results may still be excellent, but the risks of residual leak may increase. The basic message is: An In Tunnel device needs to have a Tunnel.
FlatStent EF results are optimized in PFOs with tunnel length of 4mm or more, independent of presence of aneurysm. 20

21. Potential complex anatomy for in tunnel devices

22. The IPO™ PFO Closure System

23. BD

24. BD final

25. Complex anatomy

26. CoAptus RA LA
Mechanical Coaption + Bipolar RF = Acute Seal

27. CoAptus RA LA
Mechanical Coaption + Bipolar RF = Acute Seal

28. Conclusion Unlikely to be a “one device” solution
The discs have advantages and disadvantages
Less material “left behind” has several theoretical advantages- NMT BIOTREK
Intratunnel devices are m/p the next devices to enter the market
Clips, sutures and radiofrequency will follow soon afterwards

29. Asymmetric alignment on the septum