Drug-Eluting Stent Approved for Peripheral Arterial Disease
THURSDAY, Nov. 15 -- The Zilver PTX Drug-Eluting Peripheral Stent has been approved by the Food and Drug Administration to treat peripheral arterial disease of a particular artery in the thigh.
An arterial stent is a hollow mesh tube that's used to prop open an artery that's narrowed or clogged. This stent is coated with a drug that helps prevent the artery from narrowing again.
Peripheral arterial disease (PAD) occurs when fatty material called plaque builds up on the artery wall, affecting oxygenated blood flow to the body. Symptoms could include leg pain, skin ulcers or gangrene, the FDA said in a news release.
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.
The U.S. National Heart Lung and Blood Institute has more about PAD.
Posted: November 2012