Transcatheter closure of atrial septal defect and patent foramen ovale with Carag bioresorbable septal occluder: first-in-man experience with 24-month follow-up

Introduction The Carag bioresorbable septal occluder (CBSO; CARAG AG, Baar, Switzerland) is the first interatrial septal occluder with bioresorbable framework.

Methods STUDY DESIGN The study was a single-centre, prospective, single-arm trial. Ethics committee/regulatory approvals were obtained. ClinicalTrials.gov: NCT01960491.

DEVICE DESCRIPTION The CBSO is the first occluder where the metal framework has been replaced with bioresorbable poly(lactic-co-glycolic) acid (PLGA) (Figure 1). The CBSO is self-centering, with two opposing polyester covers attached to a PLGA monofilament framework. The non-bioresorbable polyester fabric is secured to the monofilaments by platinum–iridium markers/sutures. A distal tip made of Phynox ...