PFO closure devices have been having a tough time. First the trials for treatment of migraine ran into all sorts of trouble. (See below.) Now the first trial for prevention of stroke may be in similar hot water.
Yesterday, NMT medical issued a press release with a very complicated update on the company’s CLOSURE I clinical trial of its STARFlex PFO closure device to prevent stroke and TIA. Enrollment in the trial began 5 years ago and has been problematic.
Today a story in the New York Times reports some more details. The trial was originally supposed to enroll 1,600 patients but after five years has only enrolled 900 patients, although the company believes this number may be sufficient given the number of events that have accrued over 5 years. The story quotes William Maisel, who notes that until recently neither physicians nor industry were motivated to do the necessary clinical trials, since thousands of devices were being implanted under humanitarian exemptions. Now that the FDA has cracked down on this loophole it is time to complete the trials, says Maisel.
A related New York Times story treats the saga of Peter Wilmshurst, the British cardiologist who had been a co-PI of the NMT migraine trial. He is now being sued for slander by NMT Medical. His story has been extensively covered by Shelley Wood on theheart.org (and I should state here that I was Shelley’s editor at the time, though I can’t take credit for her excellent reporting). The Times provides some new details about the case, including more detailed comments from the company’s perspective.
[…] brings on a migraine– but you can read all about it, starting with this heartwire story. We posted about this story in January, when the New York Times reported on […]