Evaluation of the safety and efficacy of the Carag Bioresorbable Septal Occluder (CBSO) to treat patients with clinically significant secundum atrial septal defect
What is the goal of the study?
The Carag Bioresorbable Septal Occluder is a transcatheter implant designed to treat clinically significant secundum atrial septal defects. CBSO is unique in that the framework of the implant is comprised of a bioresorbable material (PLGA). CBSO is intended for use in patients with a clinically significant secundum ASD, who, in the judgment of their physician, require closure of the ASD and in whom a transcatheter approach is deemed appropriate. The objectives of the investigation are to demonstrate that the safety and efficacy of the CBSO in treating clinically significant secundum ASD via transcatheter method are superior to pre-defined performance goals that are based on the safety and effectiveness data reviewed by FDA in approving the PMA applications for other ASD occluder devices currently in commercial distribution in the United States.
Who can participate in the study?
Please contact the study team listed below to learn more.