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Clinical Trial Shows That Implanted Heart Device Could Reduce Migraines

By Barnaby J. Feder
THE NEW YORK TIMES

An implanted device that repairs a congenital heart defect can reduce the frequency and severity of migraine headaches, but does not prevent the migraines altogether, according to preliminary results from the first rigorous clinical trial of the device for migraine therapy.

Although the product’s maker, NMT Medical, called the preliminary findings promising, the results disappointed investors because NMT had been seeking a definitive finding that the device could stop the headaches. Shares of the company, which is based in Boston, plunged nearly 33 percent in heavy trading on Monday after the findings were announced, closing at $14.04.

The clinical trial, which took place in Britain, used NMT Medical’s StarFlex device to close a hole between the upper chambers of the heart that as many as 25 percent of adults have from birth. Besides being linked to some types of strokes, the hole has been associated with migraine attacks among people having the congenital condition.

While the study missed its main goal of showing that closing the hole could halt migraines, it found that 42 percent of the patients reported at least a 50 percent decline in the number of days they had headaches, nearly twice as many as in the control group that did not get the device.

That result, according to doctors, analysts and NMT competitors who heard the report Monday morning at the American College of Cardiology meeting in Atlanta, reinforced the belief that there is a real if poorly understood link between the holes and migraine. “That would be a good outcome in a migraine drug trial,” said John Barr, chief executive of AGA Medical, which will shortly begin migraine trials in the United States and Europe for its own closure device.

NMT Medical said the results would be useful in designing further clinical trials. Analysts have forecast a potential multibillion-dollar market for the closure devices. More than 30 million Americans suffer various types of migraine attacks each year. Amit Hazan, who follows devices for SunTrust Robinson Humphrey, calculates that 1.5 million Americans and twice that many people in the rest of the world could be candidates for such devices.

“The flurry of activity in the investment community has been unbelievable,” said Dr. Robert Sommer, a cardiologist at Columbia University Medical Center and New York-Presbyterian Hospital. “I’ve been getting four or five calls a week looking for investment advice.”

The British study was smaller, with just 147 patients, and shorter, with just a six-month horizon, than regulators in Europe or the United States would require before approving such a therapy. The investigators, who rushed to analyze the data for presentation in Atlanta, said that many more details would be reported on at a major neurology meeting in three weeks. They noted that the number of patients who benefited grew over time and that they had found a higher-than-forecast correlation between patients with large holes and severe migraines.