FDA Panelists Reject Heart Laser Therapy

Government advisors on Monday rejected a revolutionary approach to treating heart angina--a laser that promised to relieve chronic patients’ crippling pain by zapping up to 40 tiny holes into the heart itself.

Some patients clearly showed relief from pain, advisors to the Food and Drug Administration said. But the company seeking approval to sell the treatment, PLC Medical Systems, had serious deficiencies in its study of the laser, which could even pose a risk to already-sick patients, the scientists said.

“I have a close relative who needs this procedure. There’s nothing I’d rather do than approve it,” said Dr. Robert Califf of Duke University. But he called the data supporting the laser inadequate and troubling, and on a 9-2 vote, his fellow panel members agreed.

At issue was a controversial but long-awaited procedure called transmyocardial revascularization (TMR). By blasting tiny--1 millimeter--holes into the left side of the heart, the procedure theoretically increases blood flow to portions of the muscle that have been severely damaged by advanced heart disease.

In the two-hour operation, doctors slice a 4-inch cut between the ribs to insert the laser and then blast directly into the heart. The outer layers of the heart heal almost immediately, but the beating heart forces these channels to stay open in the interior. The theory is these channels diffuse oxygenated blood into the oxygen-starved tissue and relieve the crippling chest pain known as angina.

About 150,000 Americans have end-stage coronary artery disease, which is almost always accompanied by angina. Some patients are in such pain they can hardly walk.