Gore Announces First Patient Enrolled In PRODIGY Study

Main Category: Vascular
Also Included In: Clinical Trials / Drug Trials
Article Date: 31 Mar 2008 - 3:00 PDT

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The Gore PRODIGY Study enrolled its first patient on March 17, 2008 at Georgetown University Medical Center in Washington, D.C. The procedure was performed by Richard Neville, MD.
The Gore PRODIGY (Comparison of Primary Patency Between GORE PROPATEN Vascular Graft and DIsadvantaged Autologous Vein Graft for Below-Knee Arterial BYpass) Study is a prospective, randomized, multi-center study to demonstrate non-inferiority in patency performance of the GORE PROPATEN Vascular Graft as compared to disadvantaged autologous vein graft in a below-knee peripheral bypass application. The study will involve approximately 280 patients at 20 centers throughout the United States. The patients will be followed for a period of three years and will be evaluated for several other secondary outcomes including safety, quality of life and limb salvage.

"An autologous greater saphenous vein is considered to be the gold standard for bypass procedures below-the-knee. However, it may not always be available or may be of poor quality. Prosthetic grafts have not worked well in the past. However, initial studies have shown the GORE PROPATEN Vascular Graft to be clinically effective with results approaching those of venous conduits," said Dr. Richard Neville, the principal investigator for the Gore PRODIGY study. "This landmark clinical trial will provide the medical community with valuable data that speaks to the performance of the GORE PROPATEN Vascular Graft as compared to venous conduits in these difficult clinical situations where the limb is often at risk."

"This study will provide further insights into contemporary performance benchmarks of autologous veins and prosthetic bypasses, and will add to the growing body of evidence for the GORE PROPATEN Vascular Graft" added Deenu Kanjickal, PhD, Product Specialist with Gore.

Peripheral vascular disease (PVD), also called peripheral arterial disease (PAD), affects as many as 12 million people in the US and more than 30 million worldwide. The disease manifests as a buildup of plaque in the wall of an artery and results in either narrowing or blocking of the artery, limiting blood flow to the limbs. The GORE PROPATEN Vascular Graft, which features the anticoagulant drug heparin anchored to the luminal surface, was cleared by the U.S. Food & Drug Administration (FDA) in November 2006 for peripheral use, including lower-limb bypass and dialysis access surgery. It is the first and only ePTFE-heparin combination for vascular grafts in the United States in an emerging class of medical products that combine mechanical and biological elements. It 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 using a proprietary end-point covalent bonding mechanism.

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 meshes 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.

http://www.goremedical.com

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