Second Meeting of the (EBC) European Bifurcation Club Friday 29 – Saturday 30 September 2006

1. Second Meeting of the (EBC) European Bifurcation ClubFriday 29 – Saturday 30 September 2006   Roma, Italia

2. Tryton Side-Branch Stent Dr. Aaron V. Kaplan Associate Prof of Medicine Dartmouth Medical School Cardiac Cath Lab Dartmouth-Hitchcock Medical Center

3. AV Kaplan MD: Disclosures • Tryton Medical • Founder • Board of Directors

4. Clinical Need • High Performance • Tracking = state-of-the-art stent • Guide Compatibility: 5 Fr. • Single Wire Tracking • Definitive Sidebranch Treatment • Coverage = state-of-the-art stent • Hoop Strength = state-of-the-art stent • Address all angulations

5. Tryton Design Philosophy • Axial Orientation ONLY • Rotational Orientation • Liberal Landing Zone • Tracking Performance = State-of-art Stent • Single Wire Tracking • 5 Fr guide compatible

6. Provisional Approach Driven by current Stent availability High Cross Over Rate Crossing over to poor options Dedicated Approach Driven by current stent availability Crush ‘T’ Stent Double Barrel Culotte Side-Branch Specific Stent Allows for definitive treatment Dedicated vs Provisional

7. Tryton Side-Branch Stent Side Branch Side Branch Region Standard Design Transition Zone Coverage Hoop Strength Main Vessel Main Vessel Region 3 Fronds - Minimal Coverage Wedding Band Cobalt Chromium Strut Thickness: 0.003” Diameter: 2.5 mm

8. Stent Delivery Systems Single Wire Tracking Rotational Independence Liberal (4 mm) Landing Zone Stent Border Markers (19 mm) Transition Zone Markers (4 mm) Stent Delivery System • Rapid Exchange • Low Profile • 5Fr. Guide compatible • Tracking = Zeta • Balloon • Semi-compliant • Rated Burst = 16 ATM • Stent Length = 18 mm Standard Balloon Step Balloon

9. 1. Position Side-Branch Stent Transition Zone Markers

10. 2. Deploy Side-Branch Stent

11. 3. Advance Guide Wire

12. 4. Position Main Vessel Stent

13. 5. Deploy Main Vessel Stent

14. 6. ‘Post’ Dilate Side-Branch

15. 7. Procedure Complete

16. Tryton: ‘The Movie’

17. Demonstration of Complete Coverage (OCT) Acute Porcine Model . S. Carlier, M.D. J. Moses, M.D. (Columbia/CRF)

18. Acute Porcine Studies: Gross Exam Tryton Side-Branch Stent Main Vessel Stent Main Vessel Stent Proximal Region Transition Region Distal Region Dartmouth

19. Tryton I (First-In-Man Study): Executive Committee Study Sites DSMB Design • N = 30 • Primary Endpoint • Procedural Success • In house MACE • Secondary Endpoints • Procedural:IVUS • 30 Day End Point • 6 month: Angio & IVUS • 9 month:Clinical • M-C Morice (Paris) • E Grube (Siegburg) • M Leon (Columbia/CRF) • AV Kaplan (Dartmouth) • HR Davis (Tryton) • D Kereiakes • AL Bartorelli • M-C Morice (Paris) • E Grube (Siegburg) • P Serruys (Rotterdam)

20. N = 30 Primary Endpoint Procedural Success In house MACE Secondary Endpoints Procedural: IVUS 30 Day End Point 6 month: Angio & IVUS 9 month: Clinical Design Tryton I (First-In-Man Study): Trial Design

21. Case 1: Baseline Angiography 84 yo Male with Poor LV Function Left Circumflex-Obtuse Marginal Bifurcation Lesion Medina Classification: 1,1,1

22. Case 1: Pre-Dilate Side Branch

23. Case 1: Pre-Dilate Main Vessel

24. Case 1: Deploy Tryton Stent 4 mm

25. Case 1: Angiography

26. Case 1: Pre-Dilate Main Vessel • Standard Balloon

27. Case 1: Deploy Main Vessel Stent Side Branch Main Vessel Cypher (3.5x18)

28. Case 1: Final Simultaneous Kiss • Side Branch Balloon • Main Vessel Balloon

29. Case 1: Pre-Post Comparison 84 yo Male with Poor LV Function Base Line Final Left Circumflex-Obtuse Marginal Bifurcation Lesion Medina Classification: 1,1,1

30. Tryton Side-Branch Stent • Performance = Workhorse-Stent • Cobalt Chromium • 5 Fr. Guide Compatible • Single Wire Tracking • Pre-Clinical Evaluation • Coverage • Hoop Strength • FIM-Ongoing • FIM Ongoing • >10 Cases • Initial Results Promising • Completion 4Q 06

31. The End Thank You aaron.v.kaplan@hitchcock.org