The approval covers acute Debakey Type 1 aortic dissections with either clinical or radiographic malperfusion. Atlanta-based Artivion estimates that this population comprises approximately 60% of all Debakey Type 1 aortic dissections. The condition affects approximately 6,000 patients in the U.S. each year, the company says. When left untreated, mortality comes in at approximately 1% per hour and up to 50% within the first 48 hours.
Previously, the device held FDA humanitarian device exemption (HDE). Now, hospitals no longer require institutional review board approval (IRB) to implant AMDS. This reduces administrative burden and enables more immediate treatment.
Artivion labels the device as the the world’s first aortic arch remodeling device for use in the treatment of acute DeBakey Type I aortic dissections. The company says it helps to significantly reduce the incidence of distal anastomotic new entry (DANE) tears. It complements hemiarch replacement without adding technical complexity when deployed in the aortic arch during a standard ascending aorta replacement. The device preserves the native arch, enabling minimally invasive reinterventions if needed.
FDA approval came on the heels of data from the PERSEVERE U.S. IDE trial. At 30 days, the study demonstrated a 72% reduction in all-cause mortality and a 54% reduction in primary major adverse events.
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.”
