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FDA advisers recommend approval of radiation for clogged arteries

Updated:
WASHINGTON (AP) -- Radiating the inside of coronary arteries may soon be offered to certain heart patients whose blood vessels
reclog after angioplasties: Government advisers recommended approval Monday of the first angioplasty radiation device.

About 750,000 Americans have angioplasties each year, where a balloon is threaded into arteries to push back plaque that can cause a heart attack. The procedure can work very well. But in many people, the artery reclogs, a process called restenosis.

Cardiologists thought they could solve that problem with stents, scaffolding-like devices threaded into the artery to hold it open.
But some people's arteries still reclog, as scar-like tissue builds around the stent.

It is those toughest patients that researchers hope to help by threading radiation-emitting devices inside the arteries during repeated angioplasties, in the theory that radiation might stop new clog-forming cells.

Monday, advisers to the Food and Drug Administration unanimously recommended that Cordis Corp.'s Checkmate intravascular radiation device be approved for those very severe patients, as long as the company meets some conditions. The FDA isn't bound by its advisers' recommendations but typically follows them.

Studies showed the radiation helped keep arteries open for six to nine months, said FDA cardiovascular chief James Dillard.

But the FDA questioned if radiation also prevented heart attacks and deaths, or if the procedure might cause heart attacks. The
advisers said there was too little data to be sure, so the Checkmate should be approved only if Cordis continues to study recipients for five years to settle that serious question, Dillard
said.

Using the device also will require a specially trained team of doctors, the advisers said.


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