NMT Medical's catheter device misses goal in study

Mon Nov 15, 2010 9:00am EST

* StarFlex no better than drugs in stroke prevention

CHICAGO Nov 15 (Reuters) - NMT Medical Inc's NMTI.O catheter system that closes a hole in the heart worked no better than drug therapy in preventing stroke in patients who underwent the procedure, according to data released Monday at a major medical meeting.

NMT's StarFlex system missed its primary goal in the Closure I study, failing to offer any significant benefit over medical therapy alone in patients with patent foremen ovale, or PFO, a hole between the heart's two upper chambers, researchers said.

They had sought to demonstrate the superiority of the StarFlex Septal Closure System followed by the drug clopidogrel over drug therapy with aspirin or warfarin.

There was a slight, but not statistically significant, decrease of 5.5 percent in the rate of stroke for patients in the device treatment group, compared with 7.7 percent for patients treated with drugs alone.

"It is possible the procedure has a slight benefit, but you would need thousands of patients to find it in a randomized trial," said Anthony Furlan, lead investigator of the study and chairman of the neurology department at Case Western Reserve University School of Medicine.

The findings were presented at a meeting of the American Heart Association in Chicago. (Reporting by Susan Kelly, editing by Maureen Bavdek)

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