Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel meeting on patent foramen ovale closure devices

Patent foramen ovales (PFOs) are common congenital cardiac defects that are more prevalent among patients experiencing cryptogenic stroke than among those with strokes of known origin. Medical treatment for these processes is often considered inadequate, and mechanical closure of the PFO is an attractive, albeit controversial, alternative. Although it is plausible that percutaneous PFO closure will reduce the rate of recurrent stroke in these patients, randomized trials examining the efficacy of devices in this setting have not been completed. In 2007, the Food and Drug Administration convened a meeting of the Circulatory System Devices Panel to discuss the necessity of randomized trials, as well as obstacles to trial enrollment and completion.