Transcript Slide 1

GORE VIABAHN® Endoprosthesis
Speaker’s Presentation Resource
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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Agenda
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Product Description
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Clinical Performance
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Propaten Bioactive Surface
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Latest Device Revisions
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
Product Description
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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Total Endoluminal SFA Bypass
Individual results may vary.
The GORE VIABAHN® Endoprosthesis covers and seals off the diseased
and irregular tissue of the arterial wall. In contrast, a bare nitinol stent covers
only a small portion of the diseased arterial lumen.
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
Endoprosthesis Description
Contoured proximal edge
Ultra-thin wall
ePTFE tube
Propaten Bioactive Surface
Unique, durable
bonding film
Polished nitinol
support
Lengths:
2.5, 5, 10, 15 cm
Diameters:
5 – 13 mm
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
Features and Benefits
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Nitinol Stent
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Conformable and durable
ePTFE Lining
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Covers diseased tissue
Lower Profile
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Streamlined delivery system facilitates treating challenging SFA lesions
Heparin-bonded Surface
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Intended to provide sustained thromboresistance
Contoured proximal edge
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May improve flow dynamics as blood enters endoprosthesis
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
TIP to HUB Deployment
0.035" guidewire
Guidewire Access
1. Gain access to lesion with
the guidewire.
Device Deployment
4. Slowly pull deployment
knob in a smooth motion.
Balloon Dilatation
2. Pre-dilate with appropriately
sized balloon.
Balloon Touch-up
5. Seat balloon well inside
device during touch-up.
Device Location
3. Confirm initial landing zone
before deployment.
Device Location
6. Land proximal edge at least
1 cm into healthy vessel.
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
Clinical Lessons Learned
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Avoid non-compliant lesions
Ensure adequate inflow and outflow
(e.g., at least one vessel run-off)
Correct sizing is key
Land device at least 1 cm into healthy vessel proximally and distally to the
lesion
Every region pre-treated with Percutaneous Transluminal Angioplasty (PTA)
needs to be covered by the device
During post dilatation, only balloon inside the region covered by the device
Consider an antiplatelet regimen post-procedure
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
Clinical Performance
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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Reported Primary Patency of GORE VIABAHN®
Endoprosthesis in the SFA*
Note: Patency definitions vary
* Studies including at least 30 limbs
** Prospective randomized
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
GORE VIABAHN® Endoprosthesis SFA
Average Primary Patency*
* Studies including at least 30 limbs
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
One Year Primary Patency Based
on Stented Length
*Studies including at least 30 limbs. Coats et al. did not report lesion length.
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
Original PMA
Original prospective, randomized, multicenter PMA study comparing GORE
VIABAHN® Endoprosthesis to percutaneous transluminal angioplasty in the
treatment of superficial femoral artery occlusive disease.
• Enrollment from 1998 to 1999, preceding clopidogrel availability
• Patency defined as freedom from target vessel revascularization and
peak systolic velocity ratio < 2.0 for vessel
Saxon RR, Dake MD, Volgelzang RL, Katzen BT, Becker GJ. Randomized, Multicenter Study Comparing Expanded Polytetrafluoroethylenecovered Endoprosthesis Placement with Percutaneous Transluminal Angioplasty in the Treatment of Superficial Femoral Artery Occlusive
Disease. Journal of Vascular & Interventional Radiology 2008;19:823-832.
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
Baylor Study
Prospective, randomized comparison of percutaneous GORE VIABAHN®
Devices versus prosthetic femoral-popliteal bypass in the treatment of
superficial femoral arterial occlusive disease
• “…similar primary patency at 24-month follow-up when compared with
conventional femoral-popliteal artery bypass grafting with synthetic conduit.”
McQuade K, Gable D, Hohman S, Pearl G, Theune B. Randomized comparison of ePTFE/nitinol self-expanding stent graft vs prosthetic femoralpopliteal bypass in the treatment of superficial femoral artery occlusive disease. Journal of Vascular Surgery 2009;49(1):109-116.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
DACRON® is a trademark of Invista, Inc., and is licensed to Unifi Inc.
.
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Saxon: Four Year Follow-up
Non-randomized, single-center study investigating patency of GORE VIABAHN®
Endoprosthesis in intermediate lesion lengths with four year follow-up
Saxon RR, Coffman JM, Gooding JM, Ponec DJ. Long-term Patency and Clinical Outcome of the Viabahn Stent-Grafts for Femoropopliteal
Artery Obstructions. Abstract presented at the SIR 31st Annual Scientific Meeting. Journal of Vascular & Interventional Radiology
2007;18:1341-1350.
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
GORE VIABAHN® Endoprosthesis
with Propaten Bioactive Surface
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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Unique Bioactive Heparin
Bonding Technology
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Heparin molecules are bonded directly to the surface of the endoprosthesis
– Heparin is a polysaccharide anticoagulant with a long history of clinical use.1
– Heparin has a potent antiproliferative effect on vascular smooth muscle cells.2
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A Gore proprietary end-point attachment mechanism (CARMEDA®
BioActive Surface Technology (CBAS®) allows for retention of bioactivity
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The result is an endoprosthesis intended to provide sustained
thromboresistance
1 Hirsh
J, Anand SS, Halperin JL, Fuster V. AHA Scientific statement. Guide to anticoagulant therapy: heparin. Circulation 2001;103:2994-3018.
AW, Karnowsky MJ. Suppression by heparin of smooth muscle cell proliferation in injured arteries. Nature 1977;265:625-6.
2 Clowes
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates.
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Unique Bioactive Heparin
Bonding Technology
Inside the microstructure
ePTFE fibril
Heparin molecule
Bioactive heparin site
Heparin molecules are bonded via end-point linkage
mechanism to the surface of the endoprosthesis while
retaining heparin’s activity.
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
Mechanism of Action
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Heparin molecules are bonded to the endoprosthesis surface
Bioactive site of the heparin molecule binds to antithrombin
(AT)
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Antithrombin (AT) binds to thrombin (T) – a neutral AT-T
complex is formed
Thrombin loses its ability to catalyze the conversion of
fibrinogen to fibrin
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Neutral AT-T complex detaches from the heparin molecule
Heparin bioactive site becomes available to again bind
antithrombin
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
Acute Thromboresistance
GORE VIABAHN® Endoprosthesis
with Propaten Bioactive Surface
Control Endoprosthesis
The bioactive luminal surface of a 5 mm diameter GORE VIABAHN®
Endoprosthesis with Propaten Bioactive Surface appears free of
thrombus after two hours in an in vitro blood loop model. The nonbioactive luminal surface of a control endoprosthesis (5 mm diameter)
appears covered with thrombus after 90 minutes in the same blood
loop model. (Data on file)
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
Sustained Heparin Bioactivity
• Anchored to the
endoprosthesis surface
• Bonded – does not elute
• Intended to provide
sustained thromboresistance
Long-term heparin activity of explanted heparin-bonded
ePTFE vascular grafts in a canine model
Begovac PC, Thomson RC, Fisher JL, Hughson A, Gällhagen A. Improvements in GORE-TEX® Vascular Graft performance by Carmeda®
bioactive surface heparin immobilization. European Journal of Vascular and Endovascular Surgery 2003;25(5):432-437.
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
GORE VIABAHN® with Propaten Bioactive
Surface: First Data
• 50 limbs
• 24% devices were 5 mm diameter
• - 2.3% mean change in platelet
count at 14 days
• No evidence of HIT
• 0% thrombosis at six months
Chadda N, Museitif R, Djelmami-Hani M, et al. Heparin-Bonded VIABAHN Stent
Graft for SFA Lesions: incidence of stent thrombosis and heparin-induced
thrombocytopenia. Abstract presented at the TCT 2008: Transcatheter
Cardiovascular Therapeutics 20th Annual Scientific Symposium; October 12 -17,
2008; Washington, DC. American Journal of Cardiology 2008;102(8)Supplement
1:221i.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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Latest Device Revisions
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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A New Beginning for the Proximal End
New Contoured Edge
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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GORE VIABAHN® Endoprosthesis:
Now with Contoured Edge
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New precision laser trimming technology
enables manufacturing change
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Excess graft material is removed
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Contoured trim is on proximal edge only
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
Reason for Modification
• Improves device apposition to the vessel wall when oversizing
prevents device expansion to its nominal diameter
– Contoured edge may improve flow dynamics at proximal end
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
Contoured Edge: Canine Model
IVUS demonstrates device apposition
to artery.
90 day
30 day
Post-mortem dissection demonstrates
device apposition to artery.
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
Summary of Modification
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Result of a manufacturing change implementing laser edge trimming
technology
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Excess material at the proximal edge removed
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The Instructions for Use, including sizing and placement recommendations
remain unchanged
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May improve the flow dynamics of blood entering the endoprosthesis
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
The Evolution of Performance
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Streamlined Deployment for Larger Sizes
• 9 – 13 mm diameter endoprosthesis now
incorporate the same delivery system as
the 5 – 8 mm diameter devices
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
Product Comparison
You knew it as GORE HEMOBAHN® Endoprosthesis; now it is
the next generation 9 – 13 mm diameter GORE VIABAHN®
Endoprosthesis with PROPATEN Bioactive Surface
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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Product Comparison
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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Large Diameter Deployment Changes
TIP to HUB deployment
Uniform radial expansion
– 0.035" guidewire compatibility
– Lower profile on some
configurations
HUB to TIP deployment
Unrolling expansion
– 0.025" guidewire
compatibility
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GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
Currently Enrolling Clinical Studies
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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Gore VIPER Clinical Study
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Gore VIPER Clinical Study
Heparin Bonded Surface
Contoured edge
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VIASTAR Clinical Study
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Products listed may not be available in all markets.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc. AL0752-EU3
SEPTEMBER 2009