Stents: Cook Medical gets panel date for Zilver

September 12, 2011 by MassDevice staff

The FDA's circulatory system devices advisory panel will review Cook's pre-market approval application for its Zilver-PTX stent on October 13.

Cook
FDA

Cook Medical will finally get its date with the FDA about the future of its drug-eluting stent for the treatment of peripheral arterial disease (PAD).

After over a year in the works, the federal watchdog agency's circulatory system devices advisory panel will review Cook Medical's pre-market approval application for its Zilver-PTX system on October 13. Cook filed its PMA application in June 2010. It has had CE Mark approval for sales in Europe since 2009.

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With FDA, Cook will be competing directly over the U.S. PAD market with medical device giant Medtronic, Inc. (NYSE:MDT)

"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."

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