Gore nets FDA nod of updated PAD device
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.
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.