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.
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."
Cook released the data of its ongoing trials in January at the International Symposium on Endovascular Therapy. The data, compiled from 479 patients enrolled in a randomized control trial, showed consistent outcomes over 24 months compared to one-year data. Patients receiving the self-expanding nitinol stent, which is coated with the drug paclitaxel, had 83.1 percent primary patency after 12 months and after 24 months the patency rate for the 278 patients tested was 74.8 percent.
As per standard procedure, the committee will release background material on the device two days prior to the panel.