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Lesion Coverage: Insights from the Bench TopMaciej LesiakDepartment of Cardiology University Hospital in Poznan, Poland

Disclosure Statement of Financial InterestGrant/Research SupportConsulting Fees/HonorariaAbbott VascularAbbott Vascular, AstraZeneca, Biotronik, Boston ScientificWithin 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 RelationshipCompany

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Bifurcation Lesions: Last large lesion subset not routinely treated with a stent 1st strategy

Bifurcations Treated with Tryton

Bifurcation Lesions are CommonAll Comers Studies% Patients% LesionsLeaders Trial1,229.1%21.6%Nobori 2317.5%16.9%xSearch422.2%N/A Average22.9%19.3%1. Windecker et al. Lancet 2008; 372: 1163732. Wykrzykowska, EuroPCR 093. Danzi, EuroPCR 094. Serruys, ACC 08

Bifurcation Lesions Still a ChallengeRequire more time, anxiety, skill, and equipment (cost)Increased complications peri-procedural MIs, stent thrombosis, and restenosisSuboptimal 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 diametersTotal stent length: 19mm**

Transition ZoneScaffolding at the Ostium

4.5mmSide Branch ZoneSecures the Side Branch

6.5mm*

Position Tryton StentStraddling Side Branch Origin

Proximal mid marker in MB and distal mid marker in SB

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Bifurcation Lesions Large Angle & Diameter Variation

WideNarrowAngle

SBMB

SBMBLarge DifferenceSmall DifferenceDiameter

Wide Angle

As Good as it GetsToo DistalToo ProximalWhy the need for a Dedicated Stent: Angle Variation - T Stent Provides Inadequate Coverage

Narrow Angle

As Good as it GetsToo DistalToo Proximal

Difficult to rescue: Lost Side Branch/MIPoor Coverage: RestenosisWhy the need for a Dedicated Stent: Angle Variation - T Stent Provides Inadequate Coverage

Crush TechniqueJ. Ormiston

Nordic II: Localization of In-Stent Restenosis at 8-Month Follow-up

Competitive Bifurcation Design StrategiesBalloon ExpandableSelf-Expanding

Cappella

Main VesselSide Branch

Tryton

Devax - Axxess

Stentys

Petal

FrontierInvatecTriRemeMinvasys

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Competitive Bifurcation Design StrategiesBalloon ExpandableSelf-Expanding

Cappella

Main VesselSide Branch

Tryton

Devax - Axxess

Stentys

Petal

BiossFrontierInvatecTriRemeMinvasys

No Focus on Bifurcation Not on the Market

Inadequate Ostial Coverage

Difficult

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Bifurcation Lesions: Defining The Need

Ease-of-UseTracking (Single Wire) Equipment (Operators Choice)Guide Catheters (5 or 6 Fr)GuidewiresCompatibility: any workhorse stent (DES or BMS)USER ISSUES

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Bifurcation Lesions: Defining The Need

CoverageRadial StrengthAddresses all anatomies (diameters, angulations) Ease-of-UseTracking (Single Wire) Equipment (Operators Choice)Guide Catheters (5 or 6 Fr)GuidewiresCompatibility: any workhorse stent (DES or BMS)USER ISSUESCLINICAL REQUIREMENTS

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2005 Early Design for a Crushable StentProximal extreme position

Distal extreme position

TEST DATA: Monday, 24 January 2005 (45 degree acrylic) model)POSITION RELATIVE TO CORINA:

~3mm

Proximal extremeDistal extreme

Worked well on the Bench but did not function well In Vivo

Tryton Side Branch StentCurrent Design

Wedding Band

1818

Bench Testing Used to Drive Design

Tryton Porcine ExplantsDemonstrate Complete Corinal Coverage

Tryton Demonstration of Anatomical Fit and Coverage

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Expansion range

>3.5 mm>4.5 mm

Dynamic Fatigue Testing

Used to evaluate long-term dimensional and structural integritySuccessful at 400+ Million Cycles (10 year implant life)Main Vessel and Tryton Stent/Strut Fracture

Demonstration of Anatomical Fit, Coverage, & Durability

Large Vessel DifferenceBaseline

Final

Small Vessel DifferencePre

Final

Wide AnglePreFinal

Narrow AnglePreFinal

ConclusionTryton 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!