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Drug-Eluting Peripheral Stent Continues to Show Positive Data at Two Years
Date:5/7/2010

SAN DIEGO, May 7 /PRNewswire/ -- Patients treated with the Zilver® PTX™ Drug-Eluting Peripheral Stent maintained clinical improvement at two years, according to interim results from the Zilver® PTX™ Global Registry presented today as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 33rd Annual Scientific Sessions. The prospective, single-arm study is ongoing to evaluate the drug-eluting stent for the treatment of peripheral artery disease (PAD). Results of a separate pivotal randomized study in a similar cohort of patients are expected to be available later this year.

In the meantime, this analysis includes 12-month follow-up data from 721 patients and 24-month follow-up data from 447 patients who received the Zilver® PTX™ paclitaxel-coated stent in the superficial femoropopliteal artery (SFA), a major artery above the knee. The registry study was designed to evaluate stent integrity, event-free survival and freedom from target lesion revascularization.

PAD affects more than eight million people in the U.S. and, if not treated, can limit the ability to walk and exercise, as well as place patients at risk for limb loss. PAD patients also have a greater chance of heart attack, stroke and death.

Although use of DES is common in the coronary arteries, the peripheral arteries, including those in the legs, experience different types of stress caused by walking and other movement. In some instances, blockages in these arteries are very difficult to treat, and may ultimately lead to limb amputation. The study is the third to evaluate the effectiveness of a drug-eluting stent outside of the coronary arteries, but the first to suggest clinical efficacy. The Zilver® PTX™ is an investigational device.
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