Drug-eluting stent approved for peripheral arterial disease

Drug-eluting stent approved for peripheral arterial disease

(HealthDay)—The Zilver PTX Drug-Eluting Peripheral Stent has been approved by the U.S. Food and Drug Administration to treat peripheral arterial disease of the femoropopliteal artery.

The safety and effectiveness of the stent were evaluated in a clinical study of 479 people. After one year, 83 percent of narrowed arteries treated with the new stent were still open, compared with 33 percent in a control group, the FDA said.

The most common adverse reaction observed during the study was a re-narrowing of the affected artery, which required additional treatment to restore adequate blood flow.

Among those in whom the stent should not be used are women who are pregnant, breast-feeding, or who plan to become pregnant in the next five years, the FDA said.

Device maker Cook Inc., based in Bloomington, Ind., is required to conduct a five-year post-approval study involving some 900 people who have had the stent installed, the agency said.

More information: The U.S. National Heart Lung and Blood Institute has more about peripheral arterial disease.

add to favorites email to friend print save as pdf

Related Stories

Glaucoma stent approved

Jun 26, 2012

(HealthDay) -- An ocular stent that's designed to reduce inner-eye pressure among people with mild or moderate open-angle glaucoma has been approved by the U.S. Food and Drug Administration.

Promising 3-year data: Saving limbs with drug-eluting stents

Mar 10, 2009

Attempts to treat critical limb ischemia in peripheral arterial disease (PAD) patients with below-the-knee angioplasty are still thwarted by restenosis (the re-narrowing of the artery at the site of angioplasty or stenting), ...

Recommended for you

Cerebrovascular reserve-based strategy is cost-effective

Jan 29, 2015

(HealthDay)—A decision rule based on assessment of cerebrovascular reserve (CVR) seems to be cost-effective for prevention of stroke in asymptomatic patients with carotid artery stenosis, according to a ...

New hypertension guidelines could save lives and money

Jan 28, 2015

Full implementation of new hypertension guidelines could prevent 56,000 cardiovascular disease events (mostly heart attacks and strokes) and 13,000 deaths each year, without increasing overall health care costs, an analysis ...

Manchester United's rising stars revolutionize heart health

Jan 28, 2015

A unique research project to identify the effects of exercise on young hearts has been announced today [Wednesday 28 January 2015]. Manchester United's Academy players are being put through their paces having their hearts ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.