AORT News & Events

Artivion announced that the U.S. FDA has approved the premarket approval application for the AMDS Hybrid Prosthesis. The approval covers acute Debakey Type I aortic dissections with either clinical or radiographic malperfusion, which the company estimates to be approximately 60% of all Debakey Type I aortic dissections. Given this approval, hospitals will no longer be required to obtain institutional review board approval in order to implant AMDS in their institutions, a requirement associated with the Humanitarian Device Exemption. This will reduce administrative burden on hospitals and enabling physicians to treat eligible patients more immediately and broadly across U.S. institutions.

Endospan announced that Artivion has closed the transaction to acquire the company. This strategic milestone follows the April 2026 U.S. Food and Drug Administration PMA approval of the NEXUS Aortic Arch System. The purchase price for the acquisition is $175M less offsets for previously provided loans, plus a potential for up to $200M in additional consideration contingent upon U.S. NEXUS commercial performance over the next two years. "The FDA approval of the NEXUS system was a pivotal moment for aortic surgeons seeking a technology specifically designed to treat the ascending and aortic arch," said Kevin Mayberry, Chief Executive Officer at Endospan. "With Artivion's acquisition of Endospan, this differentiated technology is being positioned within a company that understands the aortic space through a differentiated portfolio serving the multidisciplinary approach of open, endo and hybrid solutions."