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FDA OKs Treatment for Arteries

Updated:
WASHINGTON (AP) — The Food and Drug Administration approved a treatment for people whose heart arteries begin narrowing again after they have been treated to widen the blood vessels.

The agency approved two devices on Monday that use radiation to halt the renarrowing.

Stents, small metallic scaffolds, are commonly used to widen arteries that have become clogged, causing chest pain. The stent is inserted at the site where the artery is becoming blocked and helps hold the artery open.

In most of the 700,000 people treated annually the symptoms clear up, but for a few the arteries begin narrowing again due to an exaggerated healing response. Called in-stent restenosis, this problem has been very difficult to treat, the FDA said.

Now doctors will be able to use the new devices, called intravascular brachytherapy systems.

First the new blockage in the stent is reopened with a catheter that is briefly inflated like a balloon. Then the brachytherapy device is temporarily placed at the site of the blockage. It provides radiation treatment, preventing the exaggerated healing response and a recurrence of a significant block.

The two newly approved devices are the Cordis Checkmate System, sold by Cordis Corp. of Miami, and the Novoste Beta-Cath System, sold by the Novoste Corp., of Norcross, Ga.

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On the Net: FDA: http://www.fda.gov

Cordis: http://www.cordis.com/mainframe—US.cfm?page

Novoste: http://www.novoste.com/
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