NMT Medical adjusts endpoint in MIST II study

By Lisa Kerner

Charlotte, N.C., Aug. 31 - The Food and Drug Administration granted Boston-based NMT Medical, Inc. approval to adjust the primary endpoint of its pivotal heart defect foramen ovale (PFO)/migraine clinical study, MIST II, from resolution to reduction of migraine headaches.

The medical technology company will also upgrade the implant used in the 600-patient study from STARFlex to its new bioabsorbable implant, BioSTAR.

"We provided the FDA with real-time data from our recently completed BEST study and clinical evidence from our randomized, double-blinded MIST study," president and chief executive officer John E. Ahern said in a news release.

"As a result, we have transformed MIST II into a stronger, U.S.-based PFO/migraine study with a clinically relevant primary endpoint."

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