New Products In Brief

Cook Medical Inc.’s Zilver PTX became the first drug-eluting stent to gain FDA approval for peripheral arterial disease on Nov. 15. Approved via PMA, the paclitaxel-eluting nitinol stent is intended to treat peripheral arterial disease in the superficial femoral artery. The device initially will be available in 80 mm lengths, and 6 mm and 7 mm diameters, though the product’s indications also allow two 80 mm stents to be overlapped to treat longer lesions up to 140 mm, Cook said. The approval also includes 40 mm and 60 mm lengths, which will launch early next year, according to the company. Cook expects to receive approval for 120 mm-length stents in both diameters next year as well. “By the end of 2013, we expect to have a full suite of drug-eluting peripheral stents in the most commonly used lengths and diameters available to U.S. physicians,” the company stated. The device is already approved for sale in more than 50 overseas markets, including Europe, Japan, Brazil and most of South America, Australia, New Zealand and Taiwan. Two-year data from the firm’s clinical trial showed that the stent demonstrated 74.8% primary patency at 24 months, compared to 57.8% for patients treated with angioplasty and bare metal stents.

Expanded labeling for the Valiant thoracic stent graft with Captivia delivery system, approved via PMA supplement, allows use of the device for aortic transection repair, Medtronic PLC announced Nov....