The Novel PFO Specific Closure Devices: Why Did They Fail?

The potential markets of PFO closure including migraine, stroke, and sleep apnea induced the medical device industry to investigate PFO specific device alternatives to ASD indicated devices. The medical device community further recognized the unique PFO anatomy consisting of two overlapping walls as an opportunity for a minimally invasive solution. Numerous PFO specific devices were developed with either a minimal footprint or nothing left behind. Despite promising clinical results, the failure of both the randomized migraine and stroke trials led to an unclear pathway for US approval and commercialization. The investors of each of these devices eventually elected to no longer fund the development and regulatory approval of these devices. Should the RESPECT or PREMIUM Trials lead to a US indication for PFO closure we may see resurgent interest in the less invasive solutions to PFO closure.