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

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

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

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  1. Second Meeting of the (EBC) European Bifurcation ClubFriday 29 – Saturday 30 September 2006 The Cappella Sideguard Ostium Protection DeviceMichael Jonas, MDSheba Medical Center, Tel-Hashomer, IsraelBrigham and Womens Hospital, Boston, USAHarvard-MIT Biomedical Enginering Center, Cambridge, USA

  2. Separation of stent struts from vessel walls • Metal density at the carina • Injury to vessel walls • First Trumpet shape stent • First Balloon mounted delivery system for Self Expanding stent • First vertically flexible stent Cappella’s technology – clinical logic The core of the bifurcation problem - Trade off between drug delivery & flow disturbance Cappella Stent: eliminate this trade off, provide continuous coverage of the bifurcation, Novel design

  3. Cappella animation

  4. Placement of proximal marker

  5. Sideguard deployment

  6. Sideguard deployed W E S

  7. Advancement of MV stent

  8. Kissing balloons

  9. Final result

  10. Main branch @ carina Side branch @ carina IVUS pull back at level of carina Side branch anchor region

  11. CAP-ACT-S01-06 06-0714 13231 LCX-OM1-Bi-Stent 1: Main Proximal (Verhoeff 1.25x) 2: Main Mid (Verhoeff 1.25x) Distal 4: Branch Proximal (Verhoeff 1.25x) 3: Main Distal (Verhoeff 1.25x) 3 5 6 4 2 1 Branch 5: Branch Distal (Verhoeff 1.25x) Proximal Proximal Distal 6: Longitudinal Bifurcation (H&E 1.25x)

  12. CAP-ACT-S01-06:06-0704 13606 LCX-OM1-Bi-Stent Branch (image reversed) Distal MV Proximal MV 6: Longitudinal Bifurcation (H&E 1.25x)

  13. Summary of pre-clinical work • Proof of concept: bench test & animals • Ease of delivery • Excellent acute angiography • Excellent wall apposition • Feasibility with various drug coating technologies • Pre Clinical work with DES: H2 2006 • First in man Bare Metal device Q4 2006 • 30 patients BM trial in Europe Q4 2006

  14. Bare Metal clinical trial – Q4 06 Principal Investigator Dr. Wijns • Number of patients: 30 • Sites: 3 • Single Investigator per site • Period of implants: Oct 06-Jan 07 • Procedural success: deliverability, acute angiography, IVUS • Safety endpoint: 30 Day F/U (MACE) • Initial Report: 03/07 • Final report: 09/07 • Single De Novo lesions in Native Coronary Arteries Investigator Dr. Grube Investigator Dr. Colombo

  15. What’s next? - Drug coated version underway …

  16. Drug coated version – highlights of program • Coating of non-cylindrical geometry • Mechanical Integrity of Coating • Cryo Crimping / loading into sheath • Stent Expansion • Equivalence of drug elution profile • Biocompatibility

  17. Major distinguishing attributes • Trumpet shaped design perfectly conforms to a variety of ostial anatomy, providing excellent wall apposition & minimal flow disturbance. • Self expanding thin walleddesign – potentially lessening trauma & improved contact with vessel walls. • Novel balloon-sheath release mechanism for a self expanding device – improves accuracy of positioning. • Single wire low profile (3.3 Fr) system – excellent deliverability. • Familiar procedure flow • Double wires positioned in main and side branch • Kissing balloon pre-dilation • SideGuard delivered over side branch wire • Any Main Vessel stent then advanced and deployed in main vessel • Side branch re crossed, and procedure completed with a kissing balloon inflation

  18. Conclusions • A new dedicated, self expanding, side-branch ostial protection device. • Designed to solve the tradeoff between continuous drug delivery & flow disturbance. • Provides EXCELLENT deliverability & EASE of use. • Any conventional main vessel stent can be placed. • IVUS, Radiography & Histology show PERFECT expansion in both vessels, FULL luminal patency & Wall COMPLETE apposition through the ostial transition segment. • With (& perhaps without) drug elution, likely to provide superior clinical outcome in combination with DE main vessel stent.

  19. The next generation of bifurcation stenting

  20. Circumflex,Marginal 1 • * Bifurcation angle was not within Cappella specification. Bifurcation was treated for procedure • practice only.

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