NMT Looking To Broaden STARFlex Indication In Wake Of Panel Outcome
This article was originally published in The Gray Sheet
Executive Summary
NMT Medical is in discussions with FDA on the design of a trial to support a general stroke-prevention indication for its STARFlex patent foramen ovale (PFO) occluder
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NMT Medical study
Enrollment in 1,600-patient pivotal trial to evaluate STARFlex septal repair implant to treat stroke and transient ischemic attack will commence following a meeting between FDA and company reps, slated for the end of March. Conditional clearance has been granted while the firm responds to follow-up questions. In September, NMT's device was deemed "not approvable" by an FDA panel due to study design issues (1"The Gray Sheet" Sept. 23, 2002, p. 14). In the new trial, half of patients will be treated with STARFlex and the other half will receive traditional medical therapy, NMT says...