Artivion Inc. (NYSE:AORT) said the U.S. Food and Drug Administration has approved the premarket application for the NEXUS Aortic Arch System, a device developed by its partner Endospan Ltd.
The regulatory clearance gives Artivion the option to acquire Endospan within a 90-day window. The company has arranged a $150 million delayed-draw term loan to help finance a potential purchase and said it is currently evaluating whether to exercise the option following the earlier-than-anticipated approval.
NEXUS is a branched endovascular stent graft designed for minimally invasive treatment of aortic arch disease, including chronic aortic dissections. The system offers an alternative to open-chest surgery for patients who have limited treatment options.
The FDA’s decision was supported by results from the NEXUS TRIOMPHE IDE clinical trial. According to the company, the study reported 90% survival from lesion-related death, 90% freedom from disabling stroke one year after treatment, and 98% freedom from reintervention related to endoleaks at the one-year mark in a high-risk patient group.
“NEXUS receiving FDA approval ahead of our expectations is an exciting milestone for patients with aortic arch disease, for our partner Endospan, and for Artivion,” said Pat Mackin, chairman, president and chief executive officer. “We have proactively put the financing in place to support a potential acquisition, and we are moving diligently to finalize our considerations around the option.”
Artivion develops medical technologies focused on cardiac and vascular surgery, particularly treatments for aortic disease. The announcement was based on a company statement.