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

ASHG: MI without substantial CAD is minimally heritable

Oct 21, 2014

(HealthDay)—The presence of myocardial infarction (MI) without substantial coronary artery disease (CAD) is not familial, according to a study presented at the annual meeting of the American Society of ...

New treatment for inherited cholesterol

Oct 21, 2014

At the London Olympics in 2012, South African swimmer Cameron van den Burgh dedicated his world record-breaking win in the 100m breast stroke to one of his biggest rivals and closest friends, Alexander Dale ...

User comments