Artivion has secured FDA premarket approval (PMA) for its AMDS Hybrid Prosthesis, expanding the availability of the device for patients with acute DeBakey Type I aortic dissections accompanied by either clinical or radiographic malperfusion. According to the company, this patient group represents about 60% of all DeBakey Type I aortic dissections, a condition affecting approximately 6,000 people annually in the U.S. Left untreated, the condition carries a mortality rate of roughly 1% per hour, reaching as high as 50% within the first 48 hours. The PMA replaces the device’s previous FDA humanitarian device exemption (HDE), eliminating the need for hospitals to obtain institutional review board (IRB) approval before implantation and allowing faster access to treatment.
Described by Artivion as the world’s first aortic arch remodeling device for treating acute DeBakey Type I aortic dissections, the AMDS Hybrid Prosthesis is designed to reduce the incidence of distal anastomotic new entry (DANE) tears while complementing hemiarch replacement without increasing procedural complexity. The device is deployed during a standard ascending aorta replacement, preserves the native aortic arch and supports minimally invasive reinterventions when required. FDA approval follows results from the PERSEVERE U.S. IDE trial, which reported a 72% reduction in all-cause mortality and a 54% reduction in primary major adverse events at 30 days.
Pat Mackin, chair, president and CEO of Artivion, said: “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. 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.
“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.”
