Gore nets FDA nod of updated PAD device

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

W. L. Gore & Associates has received FDA approval for the Gore Viabahn Endoprosthesis with Heparin Bioactive Surface on a lower profile delivery system designed to percutaneously treat peripheral artery disease (PAD) by relining the native vessel.

This next-generation device enables a reduction in delivery profile to 6F for 5 and 6 mm devices and 7F for 7 and 8 mm devices and is delivered over a 0.018" or 0.014" guidewire, according to the Flagstaff, Ariz.-based company. Also, no changes have been made to the endoprosthesis.

This device is the only stent-graft approved for use in the superficial femoral and iliac arteries. The new iteration is available with a 120 cm long delivery catheter.