GORE, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc. 1 GORE VIABAHN ® Endoprosthesis Speaker’s.

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




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.


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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


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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


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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


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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




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


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GORE VIABAHN® Endoprosthesis SFA Average Primary Patency*

* Studies including at least 30 limbs


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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.


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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


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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® 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


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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


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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)


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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


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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.




Latest Device Revisions



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


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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


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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


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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


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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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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

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Product Comparison


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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




Currently Enrolling Clinical Studies

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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

38Products 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

GORE, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore & Associates, Inc. 1 GORE VIABAHN ® Endoprosthesis Speaker’s.

Documents

gore associates

endoprosthesis gore

configurations gore

viastar clinical study

enrolling clinical studies

diseased tissue lower

guidewire compatibility

bare nitinol stent