FDA Panel Green Lights New PAD Stent

FDA panel votes to recommend approval of the first drug eluting PAD stent

(RxWiki News) A U.S. Food and Drug Administration panel has unanimously voted to approve the first drug-eluting stent developed to treat peripheral artery disease after deeming it both effective and safe.

In an 11-0 vote the medical devices panel recommended approval of the device in what was the final step in the regulatory review process. FDA officials often approve drugs and devices approved by panels.

"Drug eluting stent soon available for peripheral artery disease."

The Zilver PTX drug-eluting stent developed by Cook Medical would be the first drug-coated stent approved to treat PAD, a common circulatory problem in which narrowed arteries reduce blood flow to the outer extremities.

The self-expanding stent marks the first paclitaxel-coated stent designed for use in symptomatic PAD of the above-the-knee femoropopliteal arteries. Common current treatments for the disease include balloon angioplasty and treatment with bare metal stents.

Rob Lyles, vice president and global leader of Cook Medical's peripheral intervention unit, said he was pleased that the panel recognized the merits of the device and looks forward to approval to market the stent in the United States in the coming months.

He called the Zilver PTX "a great example of that patient-focused business philosophy."

Cook Medical's Zilver PTX Drug Eluting Stent is currently available to be used in treatment in 48 countries, including the United Kingdom, Germany, France, Brazil, New Zealand and Taiwan. Cook Medical said about 30 million people a year are affected by PAD.

Review Date: 
October 13, 2011