FDA Approval of PFO Occlusion Device to Prevent Recurrent Stroke

The FDA has approved a patent foramen ovale (PFO) occlusion device to help prevent recurrent stroke in patients with a PFO who've had an ischemic stroke.

Approval of the Amplatzer device was based on findings from the RESPECT trial, in which 980 patients were randomized to receive the device plus medical therapy or medical therapy alone. While recurrent strokes were rare, the rate was 50% lower among patients who received the PFO occluder than among those who did not, according to the FDA.

Potential adverse effects include heart injury, atrial fibrillation, blood clots, bleeding, and stroke. Roughly 4% of patients in the RESPECT trial experienced serious adverse events related to the device or procedure (N Engl J Med 2013; 368:1092).

Of note, …