Overview of the 2016 US Food and Drug Administration Circulatory System Devices Panel Meeting on the Amplatzer Patent Foramen Ovale Occluder

On May 24, 2016, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to consider a premarket approval (PMA) application for the Amplatzer Patent Foramen Ovale (PFO) Occluder based on the results of the pivotal RESPECT trial1. In this prospective randomized multicenter open-label trial, patients with a prior cryptogenic stroke and a PFO were randomized 1:1 to “best” medical therapy or PFO closure using the Amplatzer PFO Occluder with at least 6 months of post implant antiplatelet therapy.
Source: The American Journal of Cardiology - Category: Cardiology Authors: Source Type: research