Artivion has received premarket approval from the US Food and Drug Administration (FDA) for its AMDS Hybrid Prosthesis, expanding access to the company's aortic arch remodelling technology for the treatment of acute DeBakey Type I aortic dissections accompanied by clinical or radiographic malperfusion.

The approval covers an estimated 60 percent of all acute DeBakey Type I aortic dissection cases in the United States and eliminates the need for hospitals to obtain Institutional Review Board (IRB) approval previously required under the device's Humanitarian Device Exemption (HDE). The regulatory milestone is expected to reduce administrative hurdles and enable physicians to offer the treatment more widely and without delay.

The AMDS Hybrid Prosthesis is the world's first aortic arch remodelling device designed for use alongside standard hemiarch replacement surgery in patients with acute DeBakey Type I aortic dissections. The device is intended to reduce Distal Anastomotic New Entry (DANE) tears while preserving the native aortic arch, allowing for less invasive re-interventions if required.

The FDA approval is supported by data from the PERSEVERE US Investigational Device Exemption (IDE) trial, which demonstrated a 72 percent reduction in all-cause mortality and a 54 percent reduction in major adverse events—including stroke, renal failure requiring dialysis and myocardial infarction—compared with the current standard hemiarch repair procedure at 30 days. The study also reported zero occurrences of DANE tears.

Long-term findings presented at the 62nd Annual Meeting of the Society of Thoracic Surgeons in February 2026 further reinforced the device's durability, showing continued absence of DANE tears, stable aortic dimensions, sustained expansion of the true lumen and no additional unanticipated aortic reoperations over a two-year follow-up period.

According to the company, around 6,000 patients in the United States experience acute DeBakey Type I aortic dissections each year. Without timely surgical intervention, mortality can increase by approximately 1 percent every hour, with nearly half of patients dying within 48 hours. Conventional hemiarch repair addresses the primary tear but often leaves the remaining diseased aorta vulnerable to complications, including malperfusion, aneurysm formation and repeat surgeries.

Commenting on the approval, Pat Mackin, Chairman, President and Chief Executive Officer of Artivion, said the PMA validates the positive clinical outcomes demonstrated in the PERSEVERE trial while removing barriers to broader adoption by eliminating the IRB approval requirement associated with the HDE pathway. He added that the company expects the approval to accelerate commercial adoption, supported by its existing commercial infrastructure and growing customer demand.

Mackin also noted that the approval strengthens Artivion's portfolio of aortic arch solutions, following the recent acquisition of the PMA-approved NEXUS system and ongoing clinical development of the ARCEVO LSA platform.

The PERSEVERE trial enrolled 93 patients across multiple centres in the United States to evaluate the safety and effectiveness of the AMDS Hybrid Prosthesis. Participants will continue to be followed for up to five years to assess long-term aortic remodelling outcomes and device performance.

Artivion estimates the PMA approval positions the company to fully address an annual US market opportunity of approximately USD 150 million for the treatment of acute DeBakey Type I aortic dissections. The AMDS device is already commercially available in select international markets, including Europe, Canada and parts of Asia.