Artivion’s PMA for Nexus Aortic Arch System approved by the FDA

Artivion (AORT) announced that the FDA has approved the premarket approval application, or PMA, for the Nexus Aortic Arch System, developed by Endospan, Artivion’s partner. The approval entitles Artivion to exercise its option to acquire Endospan at any time within 90 days of receiving this notice of FDA approval. Artivion has a $150M delayed draw term loan in place, secured in anticipation of this approval, to fund a potential acquisition. The company is working to complete its evaluation of the option following the earlier than anticipated approval. Nexus is a branched endovascular stent graft system approved in the U.S. for the minimally invasive treatment of aortic arch disease, including chronic aortic dissections. The FDA’s approval is supported by data from the Nexus TRIOMPHE IDE trial, which demonstrated 90% patient survival from lesion-related death, 90% freedom from disabling stroke at 1-year post treatment, and 98% freedom from reintervention due to endoleaks at one year in a high-risk patient population.