After more than a year in the works, Cook Medical’s Zilver PTX stent got a unanimous boost from the FDA’s Circulatory Systems Devices Panel, putting it on track for U.S. market clearance in the next few months.
If approved, the device will be the first of its kind for the treatment of femoropopliteal arteries.
The Zilver device is a self-expanding drug-eluting stent coated in paclitaxel and used in treatment of peripheral artery disease.
Cook filed its PMA application in June 2010, and has had CE Mark approval for sales in Europe since 2009.
"Cook Medical is very pleased that the FDA’s Circulatory System Devices Panel has recognized the merits of Zilver PTX, and we look forward to a final decision on approval to market this device in the U.S. from the FDA in the coming months,” VP and global peripheral intervention unit leader Rob Lyle said in a press release. “Cook Medical is dedicated to continually innovating and delivering medical devices that improve the quality of patient care worldwide, and we wholeheartedly feel Zilver PTX provides a great example of that patient-focused business philosophy.”
"Between the U.S. and Europe, PAD affects almost 27 million people. It is a very serious condition. Your five-year survivability with PAD is worse than several cancers, including colon cancer. It’s actually worse than if you have a heart attack," Rob Lyles, vice president & global leader of Cook Medical’s peripheral intervention unit told MassDevice last year. "There’s tremendous patient need there."
With FDA approval, Cook will be competing directly over the U.S. PAD market with medical device giant Medtronic Inc. (NYSE:MDT).