FDA Approves Unique Drug-Eluting Stent for Peripheral Artery Disease

Published date : 19 November 2012
Article date : 19 November 2012


Medcitynews reports that Cook Medical has received FDA approval for the first drug-eluting stent to treat peripheral artery disease in the US. The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding metal stent coated with the drug paclitaxel to help prevent recurring narrowing of the artery.

Drug-eluting stents are currently approved for use in coronary arteries in heart attack patients. They say that whilst Boston Scientific, Abbott Laboratories and Medtronic lead the market, Cook’s device is the first of its kind for peripheral arteries. The stent received CE Mark approval in 2009 and it is distributed in over 50 countries.

Apparently, the device is designed specifically to re-open the femoropopliteal artery in the thigh when the artery is narrowed or blocked as a result of PAD. The FDA provided that the approval expands treatment options for patients with PAD beyond existing therapies that include exercise, drug therapy, percutaneous transluminal angioplasty or bare-metal stenting.

The article goes on to say that Cook must now conduct a 5 year post-approval study of 900 patients treated with the stent to further monitor safety and efficacy. The stent will initially be available in 80 mm lengths in 6 mm and 7 mm diameters and Cook plans to offer a suite of the most commonly used lengths and diameters by the end of 2013.

Source: Deanna Pogorelc, Medcitynews.com, 15 November 2012 

Read the full, original article here.

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