India, April 7 -- Artivion, Inc. (AORT) announced that the U.S. FDA has granted premarket approval for the NEXUS Aortic Arch System, a minimally invasive stent graft designed to treat complex aortic arch disease, including chronic dissections.
This approval makes NEXUS the first branched endovascular stent graft cleared for use in the United States, offering patients a safer alternative to open-chest surgery.
The FDA's decision was supported by data from the NEXUS TRIOMPHE IDE trial, which demonstrated 90% patient survival from lesion-related death, 90% freedom from disabling stroke at one-year post treatment, and 98% freedom from reintervention due to endoleaks at one year in a high-risk patient population.
The NEXUS system was previous...