Artivion’s AMDS shows mortality reduction in late-breaking trial presentation

Artivion announced the presentation of results from the AMDS PERSEVERE clinical trial in a Late-Breaking Science presentation at the 60th Annual Meeting of the Society of Thoracic Surgeons in San Antonio, Texas. The data presented analyzed clinical outcomes across the full 93 study participant IDE cohort at 30-days following AMDS implantation. The data compares very favorably with 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, allowing continued blood flow into the false lumen created by the dissection. 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 3 years of follow up of AMDS-treated patients.