Artivion completes enrollment in PERSEVERE trial pf AMDS Hybrid Prosthesis

Artivion has completed enrollment in the PERSEVERE clinical trial, a prospective clinical trial to determine if patients with acute DeBakey Type I aortic dissection can be treated safely and effectively using the AMDS Hybrid Prosthesis. The trial is designed to support the company’s forthcoming application to the FDA for premarket approval of the AMDS. The trial will consist of 93 participants in the U.S., who have experienced an acute DeBakey Type I aortic dissection. Each participant will be followed for up to 5 years. The combined 30-day safety and primary efficacy endpoints will determine the impact of the AMDS Hybrid Prosthesis on reducing mortality, new disabling stroke, myocardial infarction, and new onset renal failure requiring dialysis, and remodeling of the aorta. The completion of the enrollment of the study keeps the study on track to achieve PMA approval in the second half of 2025.