Cook Medical’s drug-coated Zilver PTX stent met safety and efficiency standards in the treatment of peripheral arterial disease, according to a report by the FDA.
If approved, the device would be the first of its kind for the treatment of femoropopliteal arteries.
After more than a year in the works, the federal watchdog agency’s circulatory system devices advisory panel will officially review Cook Medical’s pre-market approval application for its Zilver PTX system tomorrow.
Cook filed its PMA application in June 2010. It has had CE Mark approval for sales in Europe since 2009.
"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).
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