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Restenosis

FDA Approves Two New Devices to Reduce Risk

Published in Medical Letter on the CDC and FDA, November 26th, 2000

The U.S. Food and Drug Administration has approved two new devices that administer radiation energy for treatment of in-stent restenosis.

These types of devices, called intravascular brachytherapy systems, are the first of their kind.

Coronary artery narrowing producing cardiac chest pain symptoms (angina) is a frequently encountered problem in the U.S. Approximately 700,000 patients per year have their symptoms treated by placement of a coronary stent in the narrowed artery. A stent is a metallic device that acts as a scaffold to hold the artery open at the site of the blockage.

The majority of patients who receive a coronary...

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