FDA clears GORE heparin-bonded SFA endoprosthesis.
The FDA has cleared WL Gore & Associates (Gore) to market its Gore Viabahn Endoprosthesis with Heparin Bioactive Surface for vascular bypass in the superficial femoral artery (SFA). The Gore Viabahn Endoprosthesis with heparin bioactive surface combines Gore’s proprietary heparin surface treatment with the proven performance of the Gore Viabahn Endoprosthesis for treatment of peripheral vascular disease (PVD) in the SFA. Gore Viabahn Endoprosthesis (5 to 8mm devices) is available with a new, lower-profile delivery system that gives interventionalists a more streamlined approach to re-line the SFA with a smooth ePTFE lumen supported by a highly flexible stent scaffold. The Gore Viabahn Endoprosthesis is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. According to the company, the flexibility of the Gore Viabahn Endoprosthesis enables it to better traverse tortuous areas of the SFA and conform more closely to the complex anatomy of the artery. According to the company, the endoprosthesis with heparin bioactive surface is a stent-graft and the only device of its kind on the market approved for treating the SFA. It uses end point covalent bonding to keep the heparin anchored to the endoprosthesis surface over time. The proprietary endpoint surface attachment technology preserves the heparin bioactive sites such that they remain free to interact with the blood without being consumed. According to Dr Gary Ansel, interventional cardiologist at Mid-Ohio Cardiology and Vascular Consultants and Riverside Methodist Hospital, “Clinical data has confirmed the success and safety of the Gore Viabahn Endoprosthesis for use as an endoluminal bypass. The addition of the heparinbonded ePTFE component is the first of its kind for the SFA and an exciting advancement that we are anxious to apply in our practice.” Ansel performed the first implant of the newly-approved device in the US and is a principal investigator for the Vibrant (Gore Viabahn Endoprosthesis veRsus bAre Nitinol stenT) study of comparative treatments for PAD of the SFA.