NMT Medical, a developer, manufacturer and marketer of cardiovascular devices, has presented preliminary results for Closure I, its patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) trial in the US.
Closure I is the fully enrolled, randomized clinical trial to evaluate the effectiveness of PFO treatment in preventing recurrent strokes and TIAs. Analysis of the data for Closure I commenced in April 2010.
The results showed that the trial did not achieve its primary endpoint to demonstrate that treatment by device Closure with the STARFlex technology is superior to the current best medical therapy for preventing recurrent strokes and TIAs. However, the preliminary results indicate that Closure with STARFlex provided a small, but not significant, benefit over current best medical therapy.
The trial’s preliminary results indicate that the safety profile of the STARFlex device had a low rate of complications, similar to that of current best medical therapy. In addition, there was a very low rate of thrombus formation. Closure rates in the trial were 86.5%, which is consistent with NMT’s previously reported results for the STARFlex implant, and in line with other transcatheter Closure devices.
Frank Martin, president and CEO of NMT, said: “Although we are disappointed that we did not meet the primary endpoint, we are currently in discussions with the FDA to evaluate our possible next steps relating to the stroke/TIA indication. In addition, we are working with our clinical investigators, contract research organization, and the Closure I Executive Committee to analyze the full trial data set to help us better understand and evaluate our clinical and regulatory options.
“We will update our stakeholders on our strategy going forward once we have completed some additional discussions with all parties. It is anticipated that full data results will be discussed at the American Heart Association meeting in November 2010.”