First-in-Man Clinical Investigation Begins for the Carag Bioresorbable Septal Occluder

May 14, 2014—Carag AG announced the first-in-human use of the Carag bioresorbable septal occluder (CBSO), which was implanted in a clinical investigation led by Prof. Horst Sievert, MD, and Björn Söderberg, MD, at the Cardiovascular Center Frankfurt in Frankfurt am Main, Germany. Two patients with patent foramen ovale underwent the CBSO procedure. The company expects confirmation of the clinical success of the CBSO by fall 2014.

According to Carag, previous efforts to create a septal occluder that is resorbable after facilitating defect closure have failed due to the challenges associated with resorbable frameworks. The main challenge has been with the implant staying in place on the septum and providing defect closure during the resorption process.

In the company’s press release, Prof. Sievert commented, “The procedures went very well, with good closure results. The implant was straightforward to place on the septum and easy to visualize on x-ray and echo despite not having a metal frame.”

Dr. Söderberg, who also performed the animal trials supporting the investigation, added, “This is an easy device to use, and a very important breakthrough for septal occlusion technology, one we’ve desired as physicians since the beginning of transcatheter septal closure.”