The US Food and Drug Administration (FDA) has approved the premarket approval application (PMA) for Artivion‘s AMDS hybrid prosthesis (AMDS), a press release reveals.
The approval covers acute DeBakey type I aortic dissections with either clinical or radiographic malperfusion, which the company estimates to be approximately 60% of all DeBakey type I aortic dissections.
Given this approval, hospitals will no longer be required to obtain institutional review board (IRB) approval in order to implant AMDS in their institutions, a requirement associated with the Humanitarian Device Exemption (HDE). This will reduce administrative burden on hospitals and enable physicians to treat eligible patients more immediately and broadly across US institutions, the company notes.
The AMDS is said to be the world’s first aortic arch remodelling device for use in the treatment of acute DeBakey Type I aortic dissections and has been shown to significantly reduce the incidence of distal anastomotic new entry (DANE) tears. Used as a complement to hemiarch replacement without adding technical complexity, AMDS is deployed in the aortic arch during a standard ascending aorta replacement. Artivion states that the device preserves the native arch, enabling minimally invasive reinterventions if needed.
The PMA approval is based on data from the PERSEVERE US investigational device exemption (IDE) trial, which at 30 days demonstrated a 72% reduction in all-cause mortality and a 54% reduction in primary major adverse events (MAEs), including stroke, renal failure requiring dialysis, and myocardial infarction, with zero occurrence of DANE tears, compared to the current standard-of-care hemiarch procedure.
Two-year follow-up data from PERSEVERE, presented at the 62nd annual meeting of the Society of Thoracic Surgeons (STS; 28 January–1 February, New Orleans, USA), further demonstrate the durability of these benefits, showing minimal additional mortality limited to unrelated causes, no additional unanticipated aortic reoperation, continued absence of DANE tears, and stable total aortic diameter with continued mean true lumen diameter expansion across aortic zones 1 to 6.
Artivion notes that the PMA approval of AMDS, following its commercial introduction under the HDE, positions Artivion to fully penetrate the estimated US$150 million annual US market opportunity.
