CE Mark Approval Received for 25-cm Gore Viabahn to Treat SFA

July 1, 2010—W. L. Gore & Associates (Flagstaff, AZ) announced that it has received CE Mark approval for the 25-cm Gore Viabahn endoprosthesis with Propaten bioactive surface.

According to Gore, the longer version of the device is designed to cover more of the lesion in the superficial femoral artery (SFA), potentially reducing the need for multiple devices. The recently redesigned Gore Viabahn features a precision-laser trimming technology used to remove excess material, resulting in a contoured proximal edge that may improve flow dynamics at the proximal end. Removal of excess material at the proximal edge improves device apposition to the vessel wall when oversizing prevents device expansion to its nominal diameter.

The company's Propaten bioactive surface uses endpoint immobilization of derivatized heparin to the endoprosthesis luminal surface. This surface technology preserves the heparin bioactive sites such that they remain free to interact with the blood at the device surface without being consumed.

The device is available with a low-profile delivery system and is constructed with a durable, reinforced, biocompatible, expanded-polytetrafluoroethylene liner attached to an external nitinol stent structure. The Viabahn's flexibility enables it to traverse tortuous areas of the SFA and conform more closely to the complex anatomy of the artery, the company stated.