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Lesion Coverage Insights from Bench Testing
- 1. Lesion Coverage: Insights from the Bench Top Maciej Lesiak Department of Cardiology University Hospital in Poznan, Poland
- 2. Disclosure Statement of Financial Interest • Grant/Research Support • Consulting Fees/Honoraria • Abbott Vascular • Abbott Vascular, AstraZeneca, Biotronik, Boston Scientific Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company
- 3. Bifurcation Lesions: Last large lesion subset not routinely treated with a stent 1st strategy Bifurcations Treated with Tryton
- 4. Bifurcation Lesions are Common “All Comers” Studies % Patients % Lesions Leaders Trial1,2 29.1% 21.6% Nobori 23 17.5% 16.9% xSearch4 22.2% N/A Average 22.9% 19.3% 1. Windecker et al. Lancet 2008; 372: 1163–73 2. Wykrzykowska, EuroPCR ’09 3. Danzi, EuroPCR ‘09 4. Serruys, ACC ‘08
- 5. Bifurcation Lesions Still a Challenge • Require more time, anxiety, skill, and equipment (cost) • Increased complications peri-procedural MIs, stent thrombosis, and restenosis • Suboptimal angiographic outcomes (esp. side branch ostium)
- 6. Tryton Side Branch Stent™ Main Branch Zone & wedding band 8mm *: 5.5mm for Large Vessel diameters **: 18mm for Large Vessel diameters Total stent length: 19mm** Transition Zone Scaffolding at the Ostium 4.5mm Side Branch Zone Secures the Side Branch 6.5mm*
- 7. Position Tryton Stent Straddling Side Branch Origin Proximal mid marker in MB and distal mid marker in SB
- 8. Bifurcation Lesions Large Angle & Diameter Variation Wide Narrow Angle Large Difference Small Difference Diameter
- 9. Wide Angle As Good as it Gets Too Distal Too Proximal Why the need for a Dedicated Stent: Angle Variation - ‘T’ Stent Provides Inadequate Coverage
- 10. Narrow Angle As Good as it Gets Too Distal Too Proximal Difficult to rescue: Lost Side Branch/MI Poor Coverage: Restenosis Why the need for a Dedicated Stent: Angle Variation - ‘T’ Stent Provides Inadequate Coverage
- 12. Nordic II: Localization of In-Stent Restenosis at 8-Month Follow-up
- 13. Competitive Bifurcation Design Strategies Balloon Expandable Self-Expanding Cappella MainVesselSideBranch Tryton Devax - Axxess Stentys Petal Frontier Invatec TriReme Minvasys
- 14. Competitive Bifurcation Design Strategies Balloon Expandable Self-Expanding Cappella MainVesselSideBranch Tryton Devax - Axxess Stentys Petal Bioss Frontier Invatec TriReme Minvasys No Focus on Bifurcation Not on the Market
- 15. Bifurcation Lesions: Defining The Need Ease-of-Use Tracking (Single Wire) Equipment (Operator’s Choice) – Guide Catheters (5 or 6 Fr) – Guidewires Compatibility: any workhorse stent (DES or BMS) USER ISSUES
- 16. Bifurcation Lesions: Defining The Need • Coverage • Radial Strength • Addresses all anatomies (diameters, angulations) Ease-of-Use Tracking (Single Wire) Equipment (Operator’s Choice) – Guide Catheters (5 or 6 Fr) – Guidewires Compatibility: any workhorse stent (DES or BMS) USER ISSUES CLINICAL REQUIREMENTS
- 17. 2005 Early Design for a Crushable Stent Proximal extreme position Distal extreme position TEST DATA: Monday, 24 January 2005 (45 degree acrylic) model) POSITION RELATIVE TO CORINA: ~3mm Proximal extreme Distal extreme
- 18. Tryton Side Branch Stent Current Design Wedding Band
- 19. Bench Testing Used to Drive Design
- 20. Tryton Porcine Explants Demonstrate Complete Corinal Coverage Tryton Demonstration of Anatomical Fit and Coverage
- 21. Expansion range >3.5 mm >4.5 mm
- 22. Dynamic Fatigue Testing Used to evaluate long-term dimensional and structural integrity Successful at 400+ Million Cycles (10 year implant life) Main Vessel and Tryton Stent/Strut Fracture Demonstration of Anatomical Fit, Coverage, & Durability
- 23. Large Vessel Difference Baseline Final
- 24. Small Vessel Difference Pre Final
- 27. Conclusion • Tryton stent was designed to accommodate variations in vessel caliber and angle while providing main vessel stent-like scaffolding to the ostium and side branch. • Successful bench and animal testing supports the development of Tryton stent. • Outstanding in vitro results have been confirmed in daily clinical practice.
- 28. THANK YOU!