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GORE VIABAHN ® Endoprosthesis. Speaker’s Presentation Resource. 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.

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gore viabahn endoprosthesis

GORE VIABAHN® Endoprosthesis

Speaker’s Presentation Resource

agenda
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.

total endoluminal sfa bypass
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.

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

endoprosthesis description
Endoprosthesis Description

Contoured proximal edge

Propaten Bioactive Surface

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.

features and benefits
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.

tip to hub deployment
TIP to HUB Deployment

0.035" guidewire

Guidewire Access

Balloon Dilatation

Device Location

1. Gain access to lesion with the guidewire.

2. Pre-dilate with appropriately sized balloon.

3. Confirm initial landing zone before deployment.

Device Deployment

Balloon Touch-up

Device Location

4. Slowly pull deployment knob in a smooth motion.

5. Seat balloon well inside device during touch-up.

6. Land proximal edge at least 1 cm into healthy vessel.

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

clinical lessons learned
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.

reported primary patency of gore viabahn endoprosthesis in the sfa
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.

gore viabahn endoprosthesis sfa average primary patency
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.

one year primary patency based on stented length
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.

original pma
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 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.

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

baylor study
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.

.

saxon four year follow up
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.

unique bioactive heparin bonding technology
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.

unique bioactive heparin bonding technology18
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.

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

mechanism of action
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.

acute thromboresistance
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.

sustained heparin bioactivity
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.

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
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 endoprosthesis now with contoured edge
GORE VIABAHN® Endoprosthesis:Now with Contoured Edge
  • New precision laser trimming technology enables manufacturing change
  • Excess graft material is removed
  • Contoured trim is on proximal edge only

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

reason for modification
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

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

contoured edge canine model
Contoured Edge: Canine Model

IVUS demonstrates device apposition to artery.

Post-mortem dissection demonstrates device apposition to artery.

30 day

90 day

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

summary of modification
Summary of Modification

• 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

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

streamlined deployment for larger sizes
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.

product comparison
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.

product comparison32
Product Comparison

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

large diameter deployment changes
HUB to TIP deployment

Unrolling expansion

– 0.025" guidewire compatibility

Large Diameter Deployment Changes

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 viper clinical study36
Gore VIPER Clinical Study

Heparin Bonded Surface

Contoured edge

slide38

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