A U.K. doctor finds himself in hot water amid accusations that he knowingly submitted false information about NMT Medical's StarFlex patent foramen ovale closure device as a viable treatment for migraines.
MASSDEVICE ON CALL — The U.K.'s Medical Practitioners Tribunal Service will convene later this month to consider accusations against Dr. Michael Mullen and charges that he knowingly falsified data in a trial of NMT Medical's StarFlex device as an effective treatment for migraines.
Mullen in 2007 allegedly submitted to the XXI Nordic Congress of Cardiology in Finland information that he knew to be false. Mullen submitted the same abstract at the American College of Cardiology conference in 2006, Heartwire reported.
The StarFlex implant won FDA pre-market approval in April 2009. Boston-based NMT began analyzing its closure trial data a year later, reporting in June 2010 that the device failed to meet clinical endpoints,.