Artivion Announces Presentation of Late-Breaking Data from AMDS PERSEVERE Trial at the 61st Society of Thoracic Surgery Annual Meeting

Core Insights - Artivion, Inc. announced positive one-year outcomes from the AMDS PERSEVERE clinical trial for treating acute DeBakey Type I aortic dissections complicated by malperfusion [1][3][5] Clinical Trial Data - The PERSEVERE trial involved 93 participants and demonstrated a sustained benefit of the AMDS device, with 80% of patients surviving through one year [3][6] - Key findings include a 20.4% all-cause mortality rate at one year, compared to 42.7% in historical controls, and a significant reduction in major adverse events (MAEs) [4][6] - The trial reported zero occurrences of distal anastomotic new entry (DANE) tears, which are common complications in similar procedures [4][7] Device Overview - The AMDS is the first aortic arch remodeling device designed for acute DeBakey Type I aortic dissections, allowing for rapid deployment during standard surgical procedures [7] - The device aims to improve patient outcomes by addressing complications associated with traditional hemiarch repairs, such as downstream true lumen expansion and false lumen treatment [8] Market Opportunity - Approximately 48,000 patients experience acute DeBakey Type I aortic dissections annually, representing a market opportunity of $150 million in the U.S. and$540 million globally [8] - The AMDS device is currently available in the U.S. under a Humanitarian Device Exemption (HDE) and is expected to receive premarket approval (PMA) by late 2025 [5][9]