Research In Brief
NMT PFO stroke trial comes up short: Preliminary results of the 910-patient CLOSURE I study of NMT Medical's STARFlex patent foramen ovale closure device show it is not superior to best medical therapy for preventing stroke and transient ischemic attack, the trial's primary endpoint, the firm reports June 17. Closure rates for STARFlex were 86.5%. NMT is now in discussions with FDA about the next steps relating to the stroke/TIA indication. The firm had planned to submit a PMA this year (1"The Gray Sheet" April 13, 2009). Although not statistically significant, "The preliminary data did demonstrate that our implant device provided a small benefit over current best medical therapy and maintained an excellent safety profile," NMT CEO Frank Martin notes. The company will discuss full results of the trial in November at the American Heart Association annual meeting. STARFlex is currently approved for ventricular septal defect and atrial level shunt patients. In a same-day research note, Wells Fargo analyst Larry Biegelsen speculates the CLOSURE I results could spell bad news for AGA Medical, which is conducting the RESPECT study of its Amplatzer PFO occluder in stroke. "Although there are significant differences between the CLOSURE I and RESPECT trials, we believe the CLOSURE I results will make it more challenging for physicians to close a PFO," he writes
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Class III devices and panel-track supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.
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