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Lesion Coverage: Insights from the Bench Top
Maciej Lesiak
Department of Cardiology
University Hospital in Poznan, Poland
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
Bifurcation Lesions: Last large lesion subset not routinely
treated with a stent 1st strategy
Bifurcations Treated with Tryton
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
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)
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*
Position Tryton Stent
Straddling Side Branch Origin
Proximal mid marker in MB and distal mid marker in SB
Bifurcation Lesions
Large Angle & Diameter Variation
Wide Narrow
Angle
Large
Difference
Small
Difference
Diameter
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
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
Crush Technique
J. Ormiston
Nordic II: Localization of In-Stent Restenosis at
8-Month Follow-up
Competitive Bifurcation Design Strategies
Balloon Expandable Self-Expanding
 Cappella
MainVesselSideBranch
 Tryton
 Devax -
Axxess
 Stentys
 Petal
 Frontier
 Invatec
 TriReme
 Minvasys
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
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
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
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
Tryton Side Branch Stent
Current Design
Wedding Band
Bench Testing Used to Drive Design
Tryton Porcine Explants
Demonstrate Complete Corinal Coverage
Tryton
Demonstration of Anatomical Fit and Coverage
Expansion range
>3.5 mm
>4.5 mm
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
Large Vessel Difference
Baseline Final
Small Vessel Difference
Pre Final
Wide Angle
Pre Final
Narrow Angle
Pre Final
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.
THANK YOU!

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Lesion Coverage: Insights from the Bench Top | 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
  • 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
  • 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
  • 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.