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W. L. Gore & Associates Announces Positive Interim Study Results for GORE PROPATEN Vascular Graft and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface


Interim and Pivotal Data Presented at Society of Vascular Surgery’s Annual Meeting

Flagstaff, AZ (July 22, 2008)—W. L. Gore & Associates (Gore) today announced encouraging interim results and a pivotal study update from several ongoing prospective studies for its peripheral vascular products, including the GORE PROPATEN Vascular Graft and GORE VIABAHN® Endoprosthesis. The data was recently presented to clinical audiences at the 2008 Annual Meeting for the Society of Vascular Surgery (SVS) in San Diego, California.

The ongoing GORE PROPATEN Vascular Graft studies report primary patency rates as high as 79 percent at one year for below-knee bypasses. Prior to the GORE PROPATEN Vascular Graft being available, non-heparin-bonded synthetic grafts achieved an average primary patency rate of 66 percent in below-knee bypasses at one year. Several study updates provided support for the GORE PROPATEN Vascular Graft as the synthetic graft of choice in lower-limb and dialysis access applications. These include:

  • Richard Neville, MD, reported on an ongoing study at Georgetown University Medical Center, Washington, D.C. Sixty-two below-knee bypasses were implanted for critical limb ischemia (29 percent rest pain and 71 percent ulceration/gangrene) of which 77 percent were to tibial arteries and the remaining 23 percent were bypasses to the below-knee popliteal artery. The primary patency at one, six, and twelve months for below-knee bypasses was 92 percent, 88.5 percent and 79 percent respectively by life table analysis.
  • Michael Stoner, MD, East Carolina University, Greenville, N.C., also reported on implants for above-knee and below-knee bypasses. Thirty-three above-knee and 12 below-knee GORE PROPATEN Vascular Grafts were implanted since February 2007. The majority of the below-knee implants (83 percent) had a Rutherford classification of either four or five, were tobacco users (92 percent), had poor run-off (less than two) (83 percent) and 50 percent were diabetic. The one year primary patency for the below-knee bypasses were reported to be 79 percent. The majority of the above-knee implants (97 percent) had a Rutherford classification of three, four or five, were tobacco users (64 percent) and had poor run-off (less than two) (64 percent). The one year primary patency for the above-knee bypasses were reported to be 87 percent. The above-knee GORE PROPATEN Vascular Graft implants were then compared to 169 historical implants of non-heparin-bonded grafts at the same institution and were found to have a trend towards improved primary assisted patency for patients with poor run-off.
  • William Jordan, MD, University of Alabama, Birmingham reported on 44 implants (38 lower extremity (Ten below-knee), two upper extremity, three visceral revascularization and one carotid). Thirty-nine of the 44 implants were patent at last follow-up up to one year, giving a gross patency of 89 percent.
  • Ingemar Davidson, MD, PhD, FACS, at University of Texas, Southwestern Medical Center in Dallas, Texas, presented interim results of a prospective, non-randomized study comparing GORE PROPATEN Vascular Graft to a non-heparin-bonded graft in difficult patients for hemodialysis access application. Sixty GORE PROPATEN Vascular Grafts were compared to 59 non-heparin-bonded grafts implanted since January 2007. The GORE PROPATEN Vascular Graft was generally preferred for difficult, high-risk patients. At six months, the GORE PROPATEN Vascular Grafts were found to have significant improvement of 20-25 percent in the clot free and graft survival time as compared to the control group.

“We are extremely pleased to see the positive study results of the GORE PROPATEN Vascular Graft in lower limb and dialysis access applications” said Deenu Kanjickal, PhD, Product Specialist for the GORE PROPATEN Vascular Graft. “More than 15,000 GORE PROPATEN Vascular Grafts have been successfully implanted worldwide since commercial availability.”

The GORE PROPATEN Vascular Graft is the first and only vascular graft of its kind on the market approved for the treatment of Peripheral Arterial Disease (PAD) in the lower extremities. This unique surgical graft is designed to address the gap in clinical performance between synthetic and vein grafts by bonding the anticoagulant drug heparin to the surface of the graft, with the potential to reduce thrombosis or clotting.

Additionally, Gore is pleased to release details of an interim report about the GORE VIABAHN Endoprosthesis from a study for the management of superficial femoral artery occlusive disease. Karen McQuade, MD, of Baylor University Medical Center in Dallas, Texas, reported comparable 24-month patency rates between surgical above-knee femoropopliteal bypass and endoluminal bypass.

So far in the study of 100 treated limbs, the stent-graft group is showing primary patency of 82 percent, 73 percent, and 62 percent for six months, one year, and two years, respectively.  For the same respective time points, primary patency for the surgical group, comprised of non-heparin-bonded, mostly polyester grafts, was 88 percent, 79 percent, and 65 percent. Similar secondary patency rates were seen at six months, one year, and two years (86 percent, 84 percent, and 73 percent, respectively, for stent-grafts versus 90 percent, 83 percent, and 75 percent, respectively, for the surgical grafts). According to Dr. McQuade, the interim results of this study may support the use of stent-grafts as an alternative to surgery in the management of superficial femoral artery occlusive disease.

The GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface is a stent-graft and the only device of its kind on the market approved for treating PAD in the Superficial Femoral Artery.

About W. L. Gore & Associates

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 25 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical materials for hernia repair, soft tissue reconstruction, staple line reinforcement, and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 11th consecutive year. For more information, visit http://www.goremedical.com.

Contact

Erik Clausen or Courtney Smith
Schwartz Communications, Inc. for W. L. Gore & Associates
415-512-0770 or 781-684-0770
GoreMedical@schwartz-pr.com

 

Products listed may not be available in all markets pending regulatory clearance.
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