TCT2015 Presentation - Maciej Lesiak, M.D.

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

11. Crush Technique
J. Ormiston

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

25. Wide Angle
Pre Final

26. Narrow Angle
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!