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

Exercise may protect older women from irregular heartbeat

2 hours ago

Increasing the amount or intensity of physical activity can cut the chances of older women developing a life-threatening irregular heartbeat, according to new research in the Journal of the American Heart Association (JAHA).

Huge discrepancies on heart disease in Europe

14 hours ago

Russians and Ukrainians aged 55 to 59 die from coronary heart disease at a higher rate than Frenchmen who are 20 years older, a study released Wednesday of Europe's cardiovascular health showed.

Common antibiotic linked with heart deaths

Aug 19, 2014

The antibiotic clarithromycin—widely used for treating common bacterial infections—is associated with an increased risk of heart deaths, finds a study published in the BMJ today.

User comments