Artivion has received premarket approval application (PMA) clearance from the US Food and Drug Administration (FDA) for the AMDS Hybrid Prosthesis device, permitting its use in treating acute DeBakey Type I aortic dissections with clinical or radiographic malperfusion.
As a result of this decision, US hospitals will no longer be required to obtain institutional review board (IRB) approval prior to implanting the device, a step previously mandated under the humanitarian device exemption (HDE).
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Artivion stated that this change is expected to reduce administrative processes and allow physicians to provide the device to eligible patients without these additional procedures.
The AMDS Hybrid Prosthesis is designed as an aortic arch remodelling device, used alongside hemiarch replacement surgery.
According to Artivion, the device is deployed during a standard ascending aorta replacement and preserves the native arch structure, allowing for possible minimally invasive interventions at a later stage.
The company reports that the device has been shown to reduce the incidence of distal anastomotic new entry (DANE) tears.
The approval was based on data from the PERSEVERE US investigational device exemption (IDE) trial, which included 93 participants.
At 30 days, results showed a 72% reduction in all-cause mortality and a 54% drop in major adverse events such as stroke, renal failure requiring dialysis and myocardial infarction, compared to the standard hemiarch procedure.
No DANE tears were observed in trial participants. Two-year outcomes, presented at the 62nd Annual Meeting of the Society of Thoracic Surgeons in February 2026, indicated continued absence of DANE tears and stable aortic dimensions.
Artivion chairman, president and CEO Pat Mackin 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.”
Earlier this year, Artivion debuted long-term clinical data on two of its cardiac stent products, revealing each solution’s potential to offer extended benefits to patients.
