Drug-Eluting Stent Approved for Peripheral Arterial Disease
THURSDAY, Nov. 15 (HealthDay News) -- The Zilver PTX Drug-Eluting Peripheral Stent has been approved by the U.S. 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.
-- Scott Roberts
Copyright © 2012 HealthDay. All rights reserved.
Top Stories in Heart, Blood and Circulation
Heart, Blood and Circulation Quizzes
- Blood Pressure Quiz
- Cholesterol Quiz
- Coronary Artery Disease and Angioplasty Quiz
- Coronary Artery Disease Assessment
- CPR and Defibrillator Quiz
- Dietary Fiber Quiz
- Drug Interaction Quiz
- Heart Disease Risk Quiz
- Heart Quiz for Women Only
- Medication Safety Quiz
- Nicotine Quiz
- Stress Quiz
- Trans Fat Facts and Fiction
Health News TodayFeed
- Lack of Sleep Compounds Health Problems for Obese Teens: Study03/06/2014
- Warfarin Safe for Kidney Patients With Irregular Heartbeat: Study03/04/2014
- Heart Attack Risk Rises in Hours After Angry Outburst: Study03/04/2014
- Nearly 3 Million Americans Living With Hepatitis C03/03/2014
- Diet to Reduce Blood Pressure May Also Stave Off Kidney Stones03/03/2014
- View More Heart, Blood and Circulation News