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.