GORE, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc. 1 GORE VIABAHN ® Endoprosthesis Speaker’s.
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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.1
GORE VIABAHN® Endoprosthesis
Speaker’s Presentation Resource
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Agenda
• Product Description
• Clinical Performance
• Propaten Bioactive Surface
• 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.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.3
Product Description
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Total Endoluminal SFA Bypass
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.
Individual results may vary.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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Contoured proximal edge
Propaten Bioactive Surface
Endoprosthesis Description
Ultra-thin wall ePTFE tube
Unique, durable bonding film
Polished nitinolsupport
Lengths: 2.5, 5, 10, 15 cm
Diameters: 5 – 13 mm
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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Features and Benefits
• Nitinol Stent– Conformable and durable
• ePTFE Lining– Covers diseased tissue
• Lower Profile– Streamlined delivery system facilitates treating challenging SFA lesions
• Heparin-bonded Surface– Intended to provide sustained thromboresistance
• Contoured proximal edge– May improve flow dynamics as blood enters endoprosthesis
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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TIP to HUB Deployment
1. Gain access to lesion with the guidewire.
2. Pre-dilate with appropriately sized balloon.
3. Confirm initial landing zone before deployment.
4. Slowly pull deployment knob in a smooth motion.
5. Seat balloon well inside device during touch-up.
0.035" guidewire
Guidewire Access Device Location
Device Deployment
Balloon Dilatation
Balloon Touch-up
6. Land proximal edge at least 1 cm into healthy vessel.
Device Location
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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Clinical Lessons Learned
• 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
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.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.9
Clinical Performance
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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
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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GORE VIABAHN® Endoprosthesis SFA Average Primary Patency*
* Studies including at least 30 limbs
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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One Year Primary Patency Based on Stented Length
*Studies including at least 30 limbs. Coats et al. did not report lesion length.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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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.
Saxon RR, Dake MD, Volgelzang RL, Katzen BT, Becker GJ. Randomized, Multicenter Study Comparing Expanded Polytetrafluoroethylene-covered Endoprosthesis Placement with Percutaneous Transluminal Angioplasty in the Treatment of Superficial Femoral Artery Occlusive Disease. Journal of Vascular & Interventional Radiology 2008;19:823-832.
• 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
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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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 femoral-popliteal 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.
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.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.16
GORE VIABAHN® Endoprosthesis with Propaten Bioactive Surface
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Unique Bioactive HeparinBonding Technology
• 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
• A Gore proprietary end-point attachment mechanism (CARMEDA® BioActive Surface Technology (CBAS®) allows for retention of bioactivity
• 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;103:2994-3018.2 Clowes AW, Karnowsky MJ. Suppression by heparin of smooth muscle cell proliferation in injured arteries. Nature 1977;265:625-6.
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
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.
ePTFE fibril
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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Mechanism of Action
• Heparin molecules are bonded to the endoprosthesis surface• Bioactive site of the heparin molecule binds to antithrombin
(AT)
• 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
• Neutral AT-T complex detaches from the heparin molecule• Heparin bioactive site becomes available to again bind
antithrombin
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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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 non-bioactive 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)
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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Sustained Heparin Bioactivity
• Anchored to the endoprosthesis surface
• Bonded – does not elute• Intended to provide
sustained thromboresistance
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.
Long-term heparin activity of explanted heparin-bonded ePTFE vascular grafts in a canine model
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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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.
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.23
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.24
A New Beginning for the Proximal End
New Contoured Edge
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• New precision laser trimming technology enables manufacturing change
• Excess graft material is removed
• Contoured trim is on proximal edge only
GORE VIABAHN® Endoprosthesis:Now with Contoured Edge
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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• 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
Reason for Modification
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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30 d
ay
Contoured Edge: Canine Model
IVUS demonstrates device apposition to artery.
Post-mortem dissection demonstrates device apposition to artery.
90 d
ay
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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• Result of a manufacturing change implementing laser edge trimming technology
• Excess material at the proximal edge removed
• The Instructions for Use, including sizing and placement recommendations remain unchanged
• May improve the flow dynamics of blood entering the endoprosthesis
Summary of Modification
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.
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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
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.
You knew it as GORE HEMOBAHN® Endoprosthesis; now it is the next generation 9 – 13 mm diameter GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface
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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
HUB to TIP deployment
Unrolling expansion– 0.025" guidewire
compatibility
TIP to HUB deployment
Uniform radial expansion
– 0.035" guidewire compatibility
– Lower profile on some configurations
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.
GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc.34
Currently Enrolling Clinical Studies
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