NMT Medical Inc announced that patient enrollment commenced last month in its pivotal clinical trial (CLOSURE I) comparing its STARFlex cardiac septal repair implant with current medical therapy in preventing recurrent stroke and TIA (transient ischemic attack).
Commenting on study enrollment, John E. Ahern, President and Chief Executive Officer of NMT, said, "The initiation of patient enrollment is an important milestone for NMT. We received full IDE approval from the FDA over one month ago and continue to take the necessary steps to further our competitive leadership in the regulatory arena. Based on the input of our experts, we anticipate that NMT's trial is appropriately powered to demonstrate that PFO closure using our proprietary technology is superior to current medical therapy."
As previously announced, the CLOSURE I trial is expected to enroll 1,600 patients, with half receiving the STARFlex implant, and half receiving traditional medical therapy. Follow-up will measure recurrent events over a period of two years.
More than 100 leading stroke and interventional cardiology centers in the United States have committed to participate exclusively in the study. Principal investigator for the study is Anthony Furlan, Director of the Stroke Program at Cleveland Clinic. Lead interventional cardiologist investigator in the study is Mark Reisman, Director of Cardiovascular Research at Swedish Medical Center in Seattle. Data management and analysis will be conducted by the Harvard Clinical Research Institute (HCRI) in Boston under the direction of Richard Kuntz.