Atheart Medical Inc. came on the market with splash, simultaneously announcing the company’s formation and its launch of a U.S. investigational device exemption (IDE) trial for the Resept ASD occluder, a device designed to close atrial septal defects. Resept features a metal-free, bioresorbable frame to reduce the risks associated with the long-term presence of metal in the heart.
Carag AG received investigational device exemption (IDE) approval from the U.S. FDA for its Carag Bioresorbable Septal Occluder (CBSO). The device is the first transcatheter septal occluder with a nonmetal, bioresorbable framework. The Baar, Switzerland-based company plans a "swift start" for a staged study trial in the U.S. with 250 patients, Carag's CEO Jérôme Bernhard told BioWorld.