ensure a perfect positioning and scaffolding at the sb ... · purpose of the devicepurpose of the...
TRANSCRIPT
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