Purpose of the devicePurpose of the device

• Ensure a perfect positioning andscaffolding at the SB ostium

• Avoid wire wrap

• 6 F compatible

Stent dedicated deviceStent dedicated device

Dolfin-Titan HexacatH

1- One stent for Main Branch (MB)With large cell to Side Branch (SB) access

2- Prior, guidewire pushed into SB

3- Stent approach only over a SB guidewire

video

Dolfin dedicated stentconcept

Dolfin dedicated stentconcept

Dolfin StentDolfin Stent

SB balloon Tip

Stent length 16mm; Profile 1.40 mm; 0.055 ‘’ (KT 6F 0.070 ‘’)Two independent balloons

In VITRO TestsIn VITRO TestsSilicon tube, diameter 3.0 MB, 2.5 SB, angle 30°

1 2

3 4

0.014’’ guidewire into the SB

1 2

Stent positioning into the SB

MB Balloon tip released during the pull back of the MB wire, previouslyloaded into the SB - dedicated sheath

3

Positioning of MB wire

4

SB

MB

In VITRO TestsIn VITRO Tests

First step Final step of the Dolfin stent into the bifurcation after rotation

allowing the perfect positioning of the larger dedicated cell in front

of the SB lumen

5 6

Stent positioning into the bifurcation

5

Rotation

6

In VITRO TestsIn VITRO Tests

7 8

9 10

SB Balloon inflation

7

Kissing balloon

8

Deflation of both balloons

9 10

Stent in position into the bifurcationafter balloon withdrawal

In VITRO TestsIn VITRO Tests

77 88

99 1010

Easy crossing through the SB lumen with a balloon.

Easy pull back of the balloon intothe SB lumen as well as into the larger SB -dedicated cell

Animal ExperimentAnimal Experiment

Materials and Methods• Animal model: porcine (in GLP – compliant laboratory, Paris)

• Dedicated stent deviceTwo Dolfin sizing:Balloon Diameters (mm)

MB 3,0 SB 2,53,5 3,0

Balloon length (mm) 17.5 10.5

Animal ExperimentAnimal Experiment

Technique

• Sheath: 6F femoral approach• AL2 guiding-catheter• Heparin:1mg /Kg; Clopidogrel 150mg• Angiogram:Vessel bifurcation LAD/Diagonal or

CX/Marginal branch-MB minimum diameter 3,0 mm-SB minimum diameter 2,5 mm

Animal ExperimentAnimal Experiment

Dolfin stent Implantation• First: 0.014’’ guidewire is placed into SBThe MB Guidewire is trapped into the SB balloon tip, in order to avoid wire-wrap

Image ou séq coros

Animal ExperimentAnimal Experiment

Dolfin stent Implantation• First: 0.014’’ guidewire is placed into SBThe MB Guidewire is trapped into the SB balloon tip, in order to avoid wire-wrap

Image ou séq coros

Animal ExperimentAnimal Experiment

Dolfin stent Implantation

• Second: Dolfin system is only pushedover SB guidewire.Then, MB guidewire is whithdrawn and pushed in the MB.

• Third: the stent is positioned at the carinabefore balloon inflation

Animal ExperimentAnimal ExperimentDolfin stent Implantation

Image coro 3 Image coro 4

AngiogramAngiogram

IVUS controlIVUS control

SB

SB

Stent into MB

Ostium scaffolding

SB

bifurcation

Animal ExperimentAnimal ExperimentResultsDolfin tested n = 8Dolfin size used: 3.0 x 2.5 – 16mm n = 7

3.5 x 3.0 – 16mm n = 1

Successful implantation n = 8

SB ostium recrossing successfulSB ostium patency in all casesAdditional standard SB stenting n = 4

AdvantagesAdvantages

•Safe procedure• Easy to use• No risk of Wire wrap• 6F compatible device

• Perfect positioning of the dedicatedcell in front of SB ostium

• SB ostium widely patent …• …enabling easy « Provisional T stenting »

Dolfin Next stepDolfin Next step

Continue animal trial, with 3 months FU

Obtain CE marked

Tentative First in Man 1st quarter 2009

Thank you for your attention