FDA Approves Endoprosthesis on Lower Profile Delivery System


February 21, 2011

February 21, 2011 – The U.S. Food and Drug Administration has approved an endoprosthesis device for use on a lower profile delivery system. The Gore Viabahn Endoprosthesis with Heparin Bioactive Surface, from W.L. Gore and Associates, is designed to percutaneously treat peripheral artery disease by relining the native vessel.

The next generation device enables a reduction in delivery profile to 6 Fr for 5 and 6 mm devices and 7 Fr for 7 and 8 mm devices and is delivered over a 0.0180-inch or 0.014-inch guidewire. No changes have been made to the endoprosthesis. The reduced delivery profile will provide interventionalists with greater options for delivery with the same trackability and device performance in treating stenoses and occlusions of the superficial femoral artery (SFA) and iliac artery.

“While most technology has stagnated over the past several years, W. L. Gore continues to optimize the Gore Viabahn Endoprosthesis which allows physicians to broaden the potential patient population that we can treat,” said Gary Ansel, M.D., interventional cardiologist at Riverside Methodist Hospital, Columbus, Ohio.

The endoprosthesis with Heparin Bioactive Surface is the only stent-graft approved for use in the SFA and iliac artery. The new device is available with a 120-cm long delivery catheter and incorporates the Carmeda BioActive Surface (CBAS), which utilizes end-point immobilization of derivatized heparin to the endoprosthesis luminal surface. This surface preserves the heparin bioactive sites such that they remain free to interact with the blood at the device surface without being consumed.

The Gore Viabahn Endoprosthesis was introduced in the United States in 2001. The Endoprosthesis with Heparin Bioactive Surface was approved for use in the United States in 2007. The stent-graft is constructed with a durable, reinforced, biocompatible, ePTFE liner attached to an external nitinol stent structure. The device’s flexibility enables it to better traverse tortuous areas of the SFA and iliac artery, allowing it to conform to these arteries and withstand complex mechanical motion.

For more information: www.goremedical.com