September 17, 2017
Carag Begins European Marketing After CE Mark Approval for Bioresorbable Septal Occluder
September 18, 2017—Carag AG announced that it has received European CE Mark approval for its Carag bioresorbable septal occluder (CBSO), allowing Carag to fully market the CBSO in the European Union, Switzerland, and other countries. The CBSO is a transcatheter structural heart device for treating common heart defects. The device's framework is fully resorbed by the human body.
Professor Horst Sievert, MD, performed clinical testing of the CBSO at the Cardiovascular Center in Frankfurt, Germany, where it was implanted in a series of patients with atrial septal defect or patent foramen ovale. The CBSO device demonstrated results equal to currently marketed metal framework devices.
In the company's press release, Prof. Sievert commented, “The CBSO is really a breakthrough. For decades we have been waiting for a resorbable device for transcatheter closures. Patients have already heard about this resorbable device and are asking about its availability. I am looking forward to finally providing this alternative to my patients."
Carag advised that the CBSO does not have regulatory approval in the United States and is not available for commercial distribution in the United States. The company intends to perform a clinical trial in the United States under an investigational device exemption. Additionally, Carag is negotiating with multiple international medical device companies for marketing rights.