Artivion presents data on AMDS in DeBakey aortic dissections

Artivion (AORT) announced data from the AMDS PERSEVERE clinical trial was presented in a Late-Breaking Science presentation at the 61st Annual Meeting of the Society of Thoracic Surgeons in Los Angeles. The AMDS is an aortic arch remodeling device for use in the treatment of acute DeBakey Type I aortic dissections. The data presented analyzed clinical outcomes across the full 93 study participant IDE cohort at one year following AMDS implantation. Data from the trial demonstrate sustained benefit of AMDS out to one year showing minimal new occurrence of stroke, renal failure requiring dialysis, or myocardial infarction. 80% of patients survived through 1-year with mortality after 30-days attributed to comorbidities and dissection-related complications. Follow up CT scans suggest AMDS prevents the occurrence of distal anastomotic new entry tears which compares favorably to expected rates of early reintervention and DANE tears in this patient population. DANE tears occur in up to 70% of patients following hemiarch repair without AMDS. The presence of DANE is associated with enlargement of the aorta, reoperation, and increased mortality. In contrast, DANE has not been detected in any patients in the PERSEVERE study and it was not reported in the DARTS study through 5 years of follow up of AMDS-treated patients. The company continues work with FDA towards PMA approval, which it expects to receive in late 2025.