Healthcare company NMT Medical Inc. (NMTI) Monday announced final results of its pivotal CLOSURE I study to test whether patent foramen ovale closure using STARFlex plus medical therapy is superior to medical therapy alone for preventing recurrent stroke or transient ischemic attack due to a presumed paradoxical embolism through a PFO.
The company said the final trial results did not demonstrate superiority of PFO closure with STARFlex plus medical therapy over medical therapy alone. Also, the company noted that recurring event for Starflex and for best medical therapy was statistically significant The company's shares are trading lower by over 27% on the Nasdaq.
The results were announced at the American Heart Association's Late-Breaking Clinical Trials Sessions 2010 in Chicago, Illinois.
According to NMT, CLOSURE I is the first completed, prospective, randomized, independently adjudicated patent foramen ovale device closure study. The multicenter study comprised over 900 patients, randomized 1 to 1 in each arm of either device closure or best medical therapy.
The primary endpoint was the two-year incidence of stroke or TIA, all cause mortality for the first 30 days, and neurological mortality 31 days to 2 years. The final trial results did not demonstrate superiority of PFO closure with STARFlex plus medical therapy over medical therapy alone.
At the two-year follow up period, the recurrent event rate with STARFlex was 5.9% versus 7.7% for best medical therapy, which is not statistically significant. The rate of recurrent stroke was approximately 3% in both arms. The effective closure rate of the procedure was 86.7%, based on review by a core laboratory, and is in line with other transcatheter closure devices. The results also demonstrated that recurrent stroke and TIA had multiple possible causes, often unrelated to paradoxical embolism.
NMTI is trading at $0.25, down $0.09 or 27.18%, on the Nasdaq.
For comments and feedback contact: editorial@rttnews.com
May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.