W. L. Gore & Associates Takes On Peripheral Vascular Disease At Vascular Interventional Advances (VIVA) Conference

Main Category: Vascular
Article Date: 15 Oct 2007 - 7:00 PDT

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W. L. Gore & Associates (Gore) recently took part in the fifth annual Vascular Interventional Advances (VIVA) Conference in Las Vegas, where the focus was on new technologies for combating peripheral vascular disease (PVD), also called peripheral arterial disease (PAD). At VIVA, two new studies were announced (Gore VIPER Study and Gore PRODIGY Study) that are each designed to collect important data about the performance of heparin-bonded vascular grafts in treating lower-limb PVD. In the US alone, as many as 12 million people suffer from some form of the disease, which 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 new Gore VIPER (GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface for SuPERficial Femoral Artery Endoluminal Bypass) Study is a prospective, single-arm, multi-center evaluation of the recently-approved GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface, the only stent-graft of its kind approved for treating the superficial femoral artery (SFA). Gore VIPER Study aims to collect important performance data of the heparin-bonded device. While the GORE VIABAHN® Endoprosthesis has consistently been shown to be clinically effective in treating SFA disease, there is no data available on its performance when utilizing the Heparin Bioactive Surface. The principal investigator for the study is Richard Saxon, MD, Tri-City Medical Center, Oceanside, CA.

The new Gore PRODIGY (Comparison of Primary Patency Between GORE PROPATEN Vascular Graft and DIsadvantaged Autologous Vein Graft for Below-Knee Arterial BYpass) Study is a post-marketing study with the GORE PROPATEN Vascular Graft, the only ePTFE-heparin combination cleared in the US for surgical bypass and has shown promising results in the reduction of thrombosis (clotting) in pre-clinical testing. Gore PRODIGY Study is a prospective, randomized, multi-center study designed 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. This landmark study will provide insights into performance benchmarks of autologous veins and prosthetic bypasses. The patients will be followed-up for a period of three years and will be evaluated for several other secondary outcomes including safety, quality of life and limb salvage. The principal investigator for the study is Richard Neville, MD, Georgetown University Medical Center, Washington, DC.

Much of the discussion at the conference focused on the need for improved technology for improved clinical outcomes. At a Gore-sponsored symposium, titled "The Role Of Heparin-Bonded Devices In The Treatment Of Lower Limb Arterial Disease," Dr. Saxon joined Dr. Neville in examining the impact of heparin-bonded technology on patient outcomes and selecting appropriate candidates for bypass grafting procedures.

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 and sutures for use in vascular, cardiac and general surgery. Gore was recently named the tenth best company to work for in America by Fortune.

For more information, please visit http://www.goremedical.com.

GORE, PROPATEN, and VIABAHN® are trademarks of W. L. Gore & Associates.

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