Artivion’s AMDS prosthesis shows meaningful mortality reduction

Artivion presented interim results from the AMDS PERSEVERE clinical trial at the 37th European Association for Cardio-Thoracic Surgery Annual Meeting in Vienna. The PERSEVERE trial is a 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. Interim data demonstrate clinically meaningful reduction of all-cause mortality and primary major adverse events, with 79% of participants experiencing no target MAEs at 30-days. Interim data also demonstrate excellent results for additional endpoints. The interim data compares favorably with expected rates of early reintervention and Distal anastomotic new entry – DANE – tears in this patient population. The presence of DANE is associated with enlargement of the aorta, reoperation, and increased mortality. Through this interim analysis, DANE has not been detected in any patients in the PERSEVERE study, nor was it reported in the DARTS study through 3 years of follow up of AMDS-treated patients.