March 10, 2020
European Postmarket Registry Commences for Carag Bioresorbable Septal Occluder
March 10, 2020—Carag AG, a Swiss medical device development company, announced the successful first implantation of the company’s transcatheter septal occluder with bioresorbable, metal-free framework as part of a new international postmarket registry.
The CE Mark-approved Carag bioresorbable septal occluder (CBSO) is designed to reduce complications and improve patient options for further cardiology interventions in children and adults.
The company reported that Professor Stephan Schubert, MD, implanted the CBSO in a 3-year-old patient with an atrium septum defect at the German Heart Center Berlin in Berlin, Germany, where Prof. Schubert is a senior cardiologist and Head of the Heart Catheterization Laboratory from the Department of Congenital Heart Disease—Pediatric Cardiology.
According to Carag, several leading centers in Germany, Switzerland, and other European countries will participate in the CBSO registry, which is aiming to enroll up to 100 patients. In the United States, Carag is planning to initiate a clinical study for its CBSO under an FDA investigational device exemption. The CBSO has not received regulatory approval and is not available for commercial distribution in the United States.
In Carag’s press release, Prof. Schubert commented, “The procedure went very well, with excellent closure result and flat device profile. We are excited to be able to offer this novel technology to our pediatric and adult patients.”
Prof. Felix Berger, MD, added, “Having a device without a metal framework has been a desire among physicians since the beginning of transcatheter septal closure. Thanks to its resorbable framework, the CBSO allows us to preserve all options for our patient in case we need to perform a left-sided procedure in the future.” Prof. Berger is Director of the Department of Congenital Heart Disease—Pediatric Cardiology at the German Heart Center Berlin.