GORE, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore &...

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

2

Agenda

• Product Description

• Clinical Performance

• Propaten Bioactive Surface

• Latest Device Revisions




Product Description

4

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.


5

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


6

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


7

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


8

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

10

Reported Primary Patency of GORE VIABAHN® Endoprosthesis in the SFA*

Note: Patency definitions vary* Studies including at least 30 limbs** Prospective randomized


11

GORE VIABAHN® Endoprosthesis SFA Average Primary Patency*

* Studies including at least 30 limbs


12

One Year Primary Patency Based on Stented Length

*Studies including at least 30 limbs. Coats et al. did not report lesion length.


13

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


14

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.

15

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

17

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.

18

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


19

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


20

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)


21

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


22

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

25

• 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


26

• 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


27

30 d

ay

Contoured Edge: Canine Model

IVUS demonstrates device apposition to artery.

Post-mortem dissection demonstrates device apposition to artery.

90 d

ay


28

• 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


29

The Evolution of Performance

30

Streamlined Deployment for Larger Sizes

• 9 – 13 mm diameter endoprosthesis now incorporate the same delivery system as the 5 – 8 mm diameter devices


31

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

32

Product Comparison


33

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

35

Gore VIPER Clinical Study

36

Gore VIPER Clinical Study

Heparin Bonded Surface Contoured edge

37

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 &...

Documents

Transcript of GORE, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2009 W. L. Gore &...