Artivion Gets FDA Nod For NEXUS Aortic Arch System
(RTTNews) - Artivion, Inc. (AORT) on Tuesday said that the U.S. Food and Drug Administration (FDA) has approved NEXUS Aortic Arch System, developed by its partner Endospan Ltd.
NEXUS is a branched endovascular stent graft system designed for the minimally invasive treatment of aortic arch disease, including chronic aortic dissections.
The approval entitles Artivion to exercise its option to acquire Endospan at any time within 90 days of receiving notice of the FDA decision.
The company said it has a $150 million delayed-draw term loan in place to fund a potential acquisition. Artivion added that it is actively evaluating the option following the earlier-than-expected approval.
The FDA's approval was supported by data from the NEXUS TRIOMPHE IDE trial, which showed 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.
Shares of Artivion closed at $33.45 on Monday, down 2.11%.
