Artivion Wins FDA Nod for AMDS Hybrid Prosthesis

Artivion has gained U.S. Food and Drug Administration (FDA) approval for its AMDS Hybrid Prosthesis.

The approval covers acute Debakey Type I aortic dissections with either clinical or radiographic malperfusion, which the company estimates to be about 60% of all Debakey Type I aortic dissections.

The AMDS is the first aortic arch remodeling device used to treat acute DeBakey Type I aortic dissections and was demonstrated to reduce the incidence of distal anastomotic new entry (DANE) tears. AMDS complements hemiarch replacement without adding technical complexity. Rapidly deployed during standard ascending aorta replacement, it preserves the native arch and enables minimally invasive re-interventions if needed.

The PMA approval is supported by data from the PERSEVERE U.S. IDE trial, which showed a 72% reduction in 30-day all-cause mortality, a 54% reduction in major adverse events (stroke, dialysis-dependent renal failure, and myocardial infarction), and zero distal anastomotic new entry (DANE) tears compared with standard hemiarch repair. Two-year data, presented at the 62nd Annual Meeting of the Society of Thoracic Surgeons in February, showed durable outcomes with minimal unrelated mortality, no unanticipated aortic reoperations, continued absence of DANE tears, stable total aortic diameter, and sustained true lumen expansion across aortic zones 1-6.

“We are thrilled to receive AMDS PMA approval, as it not only validates the enduring benefits shown in the PERSEVERE clinical data but also removes a barrier to broader adoption by eliminating the IRB requirement that came with the HDE,” said Pat Mackin, chairman, president, and CEO of Artivion. “Having already built commercial and clinical infrastructure during our HDE launch, and with strong reordering momentum among accounts already using AMDS, we expect this PMA to help accelerate adoption of this life saving technology.”

Mackin added, “This approval, following our recent acquisition of the PMA-approved NEXUS system and continued clinical trial enrollment progress for ARCEVO LSA, marks another step forward in our vision of Artivion as the only company globally with a complete portfolio of market leading aortic arch solutions. We are deeply grateful to every PERSEVERE investigator and patient who helped make this possible.”

Last month, the company closed a $175 million deal for aortic arch maker Endospan, marking the integration of Endospan’s Nexus system into a comprehensive global portfolio of solutions to treat the aortic arch.