FDA approves Artivion’s NEXUS system for aortic arch disease

The FDA has approved Artivion’s NEXUS Aortic Arch System, clearing the minimally invasive device for use in aortic arch disease in the United States.

Artivion said the approval covers Endospan’s branched endovascular stent graft system, which is designed to treat aortic arch disease, including chronic aortic dissections. The company said the FDA decision was supported by one-year TRIOMPHE IDE trial data.

In its April 7 announcement, Artivion said the approval also triggers a key strategic milestone: the company has the option to acquire Endospan within 90 days of notice. Artivion said it has a $150 million delayed-draw term loan in place to support a potential acquisition.

Independent market coverage later the same day confirmed the FDA approval and repeated the main deal terms. Company sources said the approval came earlier than expected.

The NEXUS system adds a new U.S. option in aortic arch disease, a complex area of cardiovascular care where minimally invasive approaches have been developing quickly.

The announcement is important both as a regulatory milestone and because it may reshape Artivion’s relationship with Endospan if the company exercises its acquisition option.