ASSURED clinical study: New GORE® CARDIOFORM ASD occluder for transcatheter closure of atrial septal defect.
Robert J SommerBarry A LoveJoseph A PaolilloRobert G GrayBryan H GoldsteinGareth J MorganMatthew J Gillespienull nullPublished in: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (2020)
The GCA performed effectively and safely in this initial cohort, and led to FDA approval based on this data.