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Artivion Announces U.S. FDA Approval of the AMDS Hybrid Prosthesis
Artivion Announces U.S. FDA Approval of the AMDS Hybrid
About this update from Artivion, Inc.
ATLANTA, June 29, 2026 /PRNewswire/ -- 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.The AMDS is the world's first aortic arch remodeling device for use in the treatment of acute DeBakey Type I aortic dissections and has been shown to significantly reduce the incidence of distal anastomotic new entry (DANE) tears. Used as a complement to hemiarch replacement without adding technical complexity, AMDS is rapidly deployed in the aortic arch during a standard ascending aorta replacement. The device preserves the native arch, enabling minimally invasive re-interventions if needed. The PMA approval is based on data from the PERSEVERE U.S. IDE trial, which at 30 days demonstrated a 72% reduction in all-cause mortality and a 54% reduction in primary major adverse events (MAEs), including stroke, renal failure requiring dialysis, and myocardial infarction, with zero occurrence of distal anastomotic new entry (DANE) tears, compared to the current standard of care hemiarch procedure. Two-year follow-up data from PERSEVERE, presented at the 62nd Annual Meeting of the Society of Thoracic Surgeons in February 2026, further demonstrate the durability of these benefits, showing minimal additional mortality limited to unrelated causes, no additional unanticipated aortic reoperation, continued absence of DANE tears, and stable total aortic diameter with continued mean true lumen diameter expansion across aortic zones 1 to 6.Each year, approximately 6,000 patients in the U.S. present with an acute DeBakey Type I aortic dissection, an emergent, life-threatening condition requir...