Core Insights - Artivion, Inc. presented significant clinical trial data at the 38th EACTS Annual Meeting, showcasing the effectiveness of its AMDS Hybrid Prosthesis and E-vita Open Neo in treating aortic diseases [1][3]. Group 1: AMDS DARTS Trial - The 5-year data from the AMDS DARTS trial indicates that 94% of patients were free from aortic reoperation, significantly higher than the 76% reported in existing literature for hemiarch-only outcomes [4][5]. - Additionally, 95% of patients showed no total aortic diameter (TAD) growth greater than 5 mm between the 3-year and 5-year follow-up periods [4]. - The trial involved 25 out of 46 participants with acute DeBakey Type I dissection, demonstrating durable benefits over five years [4][10]. Group 2: AMDS PERSEVERE Trial - The 30-day data from the AMDS PERSEVERE trial revealed that 90% of patients with pre-operative cerebral malperfusion experienced resolution post-implantation [6][7]. - Among those with cerebral malperfusion, 63% had complete resolution, while 26% showed no worsening of symptoms [6]. - The trial's stroke occurrence rate was 10.8%, significantly lower than the 20.9% reported in literature for hemiarch procedures [7]. Group 3: E-vita Open Neo NEOS Study - The 1-year data from the NEOS study indicated a mortality rate of 9.9% for E-vita Open Neo, which is better than the 10.8% for the current market-leading device [8][9]. - The combined major adverse events rate for E-vita Open Neo was 17%, compared to 23.1% for the leading alternative [8]. - The study included 161 participants and demonstrated the safety and effectiveness of E-vita Open Neo in treating aortic arch pathologies [8][13].
Artivion Announces Presentation of Late-Breaking Clinical Data at the 38th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting