Does PFO closure prevent stroke?: The CLOSURE I trial
Interviewed by Steven Greer, MD
(In full screen 1080 HD for better viewing of the data graphs)
Neurologist S. Claiborne Johnston, M.D., Ph.D. of UCSF reviews the NMT Medical plagued CLOSURE I trial testing the hypothesis that early closure of patent foramen ovales (PFO’s) reduces the incidence of cryptogenic stroke caused by paradoxical emboli. The study was redesigned in midcourse due to slow enrollment. Insurance reimbursement for off-label PFO closure was diverting eligible patients. In addition, some of the patients highest at risk were excluded from the trial.
Dr. Johnston discusses what clinicians should take away from the flawed data and mentions a second similar trial with results expected this year. The larger topic of medical device approval in the U.S. is discussed.
Cardiology/interventional, NEJM, Neurology, UCSF | apples49 | 
October 28, 2013 12:12 pm
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By Joe Selby, March 16, 2012 @ 8:03 am
Nice job Clay! Good to see you. And good discussion of the negative effect of pre-approval reimbursement.