|Cook Medical's Zilver PTX is the first drug-eluting stent FDA approved for peripheral artery disease--courtesy of Cook Medical|
The FDA has approved Cook Medical's Zilver PTX to treat peripheral artery disease, making the device the first drug-eluting stent indicated for PAD in the U.S.
Zilver PTX is self-expanding device inserted into the femoral artery that emits paclitaxel to prevent restenosis during stenting. In two PMA studies, the device was found to be almost three times as effective as percutaneous transluminal angioplasty and just as safe for patients with PAD in above-the-knee femoropopliteal artery, the FDA said.
The FDA's blessing goes a long way, and Gary Ansel, director for the Center for Critical Limb Care at Ohio's Riverside Methodist Hospital, said this approval could revolutionize PAD treatment the way drug elution did for coronary artery disease.
"Drug-eluting stents such as Zilver PTX will move quickly, in my opinion, to become the standard of care for PAD patients worldwide," Ansel said in a statement.
Being first on the market is an enormous benefit, Cook Vice President Rob Lyles said, and the company is excited to provide a new treatment option for U.S. PAD patients.
"No other company can match Cook's commitment to this technology, and 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," Lyles said in a statement.
Cook got a CE mark for Zilver PTX back in 2009, and the device is already commercially available in more than 50 countries, the company said. The FDA's full approval follows a unanimous recommendation from the agency's Circulatory System Devices Advisory Committee last year.
- read the FDA's announcement
- here's Cook's release
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