The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

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

DOI: 10.4244/EIJ-D-21-00740

1. CardioVascular Center Frankfurt CVC, Frankfurt, Germany; 2. Department of Pediatrics at Institute of Clinical Sciences, Gothenburg University, Gothenburg, Sweden; 3. University of Dundee, Dundee, United Kingdom; 4. Klinikum Kassel, Kassel, Germany
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 ...

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