NMT Medical says firm's STARFlex technology shown to reduce migraines

By Ted A. Knutson

Washington, March 13 - NMT Medical, Inc said Monday new research shows that the company's STARFlex technology can reduce migranes through closing a patent foramen ovale (PFO).

The results of the MIST (Migraine Intervention with STARFlex Technology) study were announced at the American College of Cardiology's 55th Annual Scientific, Late-Breaking Clinical Trials Sessions.

MIST results indicated an approximate 37% reduction in migraine burden (number of headaches multiplied by the length, in hours of headache) in those patients who received a STARFlex implant and a 17% reduction in those who received the sham procedure and no implant. This represents a statistically significant treatment effect. It also was reported that this variance appears to increase over time.

The study, which screened 432 migraine with aura patients for a PFO, enrolled 147 patients into the study. A significant finding in the MIST study is that more than 60% of those screened had a right to left shunt.

A shunt is a heart defect, which allows blood to cross from the right to left chambers of the heart, bypassing the lungs. Of those patients, almost 40% had a moderate or large PFO, six times greater than the general population.

Consistent with what was reported in the observational studies, researchers selected a challenging primary endpoint of 40% elimination in migraine headache at six months in the treatment group.

"Preliminary analysis of MIST data did not satisfy that endpoint, however, we are seeing a significant treatment effect and promising trend to support PFO closure with STARFlex as a treatment option for certain types of migraine," said co-primary investigator Dr. Peter Wimshurst in a press release. Wilmshurst is consultant cardiologist at Royal Shrewsbury Hospital, Shrewsbury, England.

NMT is an Atlanta-based medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat cardiac sources of migraine headaches, stroke and other potential brain attacks.

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