Healthcare Industry News: endoprosthesis
News Release - October 18, 2007
First Patient Enrolled in Study of the GORE VIABAHN(R) Endoprosthesis with Heparin Bioactive Surface for Lower Limb Peripheral Vascular Disease
FLAGSTAFF, Ariz.--(HSMN NewsFeed)--The first patient to enter a post-market evaluation designed to collect important data about the performance of the GORE VIABAHN® endoprosthesis with Heparin Bioactive Surface in treating lower limb peripheral vascular disease (PVD) has undergone a successful implant. The procedure was performed on October 9th by Richard Saxon, MD, Tri-City Medical Center in Oceanside, CA. The device was used to treat a long segment occlusion of the superficial femoral artery (SFA).PVD, also called peripheral arterial disease (PAD), affects as many as 12 million people in the US. 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 VIABAHN® endoprosthesis with Heparin Bioactive Surface was approved by the FDA in July 2007 for the treatment of occlusive disease in the SFA.
“The implant procedure went quite well and we will monitor the patient carefully to measure long-term performance of the endoluminal bypass,” said Dr. Saxon, the principal investigator for the study. “While the GORE VIABAHN® endoprosthesis has been shown to be clinically effective, there is no data on its performance when using the Heparin Bioactive Surface. We aim to fill this data gap through the Gore VIPER study.”
The 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 GORE VIABAHN® endoprosthesis with Heparin Bioactive Surface. The Gore VIPER Study aims to collect important performance data of the device in the SFA, which combines Gore’s proprietary heparin surface treatment with the proven performance of the GORE VIABAHN® endoprosthesis. The GORE VIABAHN® endoprosthesis with Heparin Bioactive Surface utilizes the same bioactive heparin surface technology that is present on the GORE PROPATEN Vascular Graft.
The GORE VIABAHN® endoprosthesis with Heparin Bioactive Surface uses end-point covalent bonding to keep the heparin anchored to the endoprosthesis surface over time. The proprietary end-point surface attachment technology preserves the heparin bioactive sites such that they remain free to interact with the blood without being consumed. The GORE VIABAHN® endoprosthesis with Heparin Bioactive Surface utilizes the recently released reduced profile delivery system. The excellent flexibility of the device enables it to better traverse tortuous areas of the SFA and conform closely to the complex anatomy of the 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 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, visit http://www.goremedical.com.
GORE and VIABAHN® are trademarks of W. L. Gore & Associates.
Source: W. L. Gore
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