Aortic Arch Remodeling Device Improves Type I Dissection Repair

Rapid ischemic complications and high early mortality make durable repair a priority for hospital teams. Standard hemiarch repair removes the primary entry tear but can leave residual disease that drives complications and reinterventions. To help address this challenge, a newly approved technology aims to remodel the aortic arch during index surgery.

Artivion’s AMDS Hybrid Prosthesis is an aortic arch remodeling device used in conjunction with hemiarch replacement. The device is rapidly deployed in the arch during a standard ascending aorta replacement and is designed not to add technical complexity. It preserves the native arch anatomy, which can facilitate minimally invasive re-interventions if they become necessary.

The U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for AMDS to treat acute DeBakey Type I dissections with clinical or radiographic malperfusion, a group estimated to represent about 60% of these dissections. With this approval, hospitals no longer need institutional review board authorization previously required under the Humanitarian Device Exemption, reducing administrative burden and enabling broader availability across U.S. institutions.

Approval was supported by the PERSEVERE U.S. Investigational Device Exemption trial, a prospective, multicenter, non-randomized study of 93 participants with acute DeBakey Type I dissections complicated by malperfusion. At 30 days, AMDS use was associated with a 72% reduction in all-cause mortality and a 54% reduction in primary major adverse events, including stroke, renal failure requiring dialysis, and myocardial infarction, with zero distal anastomotic new entry tears compared with standard hemiarch repair. Each participant will be followed for up to five years to assess aortic remodeling outcomes.

Two-year PERSEVERE data presented at the Society of Thoracic Surgeons 62nd Annual Meeting in February 2026 showed durability of benefit, including minimal additional mortality limited to unrelated causes, no additional unanticipated aortic reoperations, continued absence of distal anastomotic new entry tears, and stable total aortic diameter with ongoing true lumen expansion across aortic zones 1 through 6. Approximately 6,000 patients in the U.S. present annually with acute DeBakey Type I dissection, and untreated mortality is reported to approach 1% per hour and up to 50% within 48 hours.

“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 Chief Executive Officer 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.

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