Artivion, Inc. (NYSE:AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced that the U.S. Food and Drug Administration (FDA) has approved the premarket approval application (PMA) for the AMDS Hybrid Prosthesis ("AMDS"). 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 (IRB) approval in order to implant AMDS in their institutions, a requirement associated with the Humanitarian Device Exemption (HDE). This will reduce administrative burden on hospitals and enabling physicians to treat eligible patients more immediately and broadly across U.S. institutions.