Vascular Surgeons Present Positive Study Results For The GORE PROPATEN(R) Vascular Graft And Updates To The GORE VIABAHN(R) Endoprosthesis

Main Category: Vascular
Article Date: 20 Sep 2009 - 0:00 PDT

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W. L. Gore & Associates (Gore) announced that several physicians recently presented interim data from ongoing GORE PROPATEN® Vascular Graft studies to clinical audiences at the 2009 annual vascular meeting. The conference, the premier event hosted by the Society for Vascular Surgery (SVS), was held in mid-June in Denver, Colorado. One physician reported primary patency rates as high as 100 percent for below-knee bypasses.

Study updates presented at this year's SVS meeting support the use of the GORE PROPATEN Vascular Graft as the prosthetic device of choice in lower limb and dialysis access applications. Results included:

Edward Woo, MD, University of Pennsylvania, Philadelphia, reported on 45 implants and that the GORE PROPATEN Vascular Graft handles well and implantation was well tolerated among all patients, with no increased bleeding at anastomoses and no postoperative platelet issues reported. The one-year primary patency rate was 92.3 percent. Based on this data, Dr. Woo recommends the GORE PROPATEN Vascular Graft as the graft of choice for lower extremity prosthetic bypass.

Syed Hussain, MD, Heartcare Midwest of Peoria, Illinois, reported on 46 above-knee and 24 below-knee GORE PROPATEN Vascular Grafts. He associated the use of the grafts with decreased operative time and length of hospital stay, as well as good quality of life. Dr. Hussain concluded that GORE PROPATEN Vascular Grafts are an excellent conduit for above-knee and below-knee popliteal bypass grafting, with primary patency at 96 percent (mean follow-up 16.7 months) and 100 percent (mean follow-up 15.8 months), respectively.

Stephen Settle, MD, Cardiovascular and Thoracic Surgeons of Austin, Texas, presented a case study on a 35-year old female patient with lupus. While lupus patients tend to have an increase in clotting episodes, this patient remained clot free for one year with the GORE PROPATEN Vascular Graft. Dr. Settle has implanted approximately 380 GORE PROPATEN Vascular Grafts, including 31 in high-risk patients, and has only reported one case of early thrombosis.

At the meeting, Dr. Settle also shared results of Ingemar Davidson, MD, PhD, FACS, at University of Texas, Southwestern Medical Center in Dallas, Texas. Dr. Davidson reports a preference for the GORE PROPATEN Vascular Graft for difficult, high-risk patients. At 12 months, 78 percent of patients were clot free and saw a 20 percent improvement in clot free survival as compared to the control group.

"With more than 30,000 implants, we are pleased that physicians implanting the GORE PROPATEN Vascular Graft have consistently experienced positive results, even when working with challenging cases," said Jennifer Recknor, PhD at Gore Medical. "The high patency rates, coupled with improved thromboresistance, further solidify the device's position as the prosthetic vascular graft of choice in lower limb and dialysis access applications."

The GORE PROPATEN Vascular Graft is the first and only vascular graft of its kind on the market approved for hemodialysis access and the treatment of Peripheral Artery Disease (PAD). This unique surgical graft is designed to address the gap in clinical performance between prosthetic and autologous vein grafts by providing a bound heparin technology on the luminal surface that retains its thromboresistant bioactive properties over time. As many as 12 million Americans over the age of 50 are affected by PAD and an estimated 400,000 end-stage renal disease (ESRD) patients are on hemodialysis.

In a separate presentation, Darren B. Schneider, MD, Associate Professor of Vascular Surgery and Radiology at the University of California, San Francisco, reported on the recently announced manufacturing change to the GORE VIABAHN® Endoprosthesis.

The manufacturing change discussed by Dr. Schneider is a result of precision laser trimming technology, which enables the removal of excess material at the device margin, resulting in a contoured edge. He expressed his hope that the laser contoured edge at the proximal end may improve flow dynamics of blood entering the endoprosthesis. The device is the only stent-graft approved by the FDA for the treatment of patients suffering from PAD in Superficial Femoral Artery (SFA) lesions and iliac artery lesions.

Source
W. L. Gore & Associates