Artivion Inc.
(NYSE:AORT) said Monday that the U.S.
Food and Drug Administration has approved the premarket approval application for its AMDS Hybrid Prosthesis, broadening access to the device for patients suffering from acute DeBakey Type I aortic dissections with clinical or radiographic malperfusion.
The medical device company focused on developing solutions for cardiac and vascular surgeons.
The approval eliminates the need for hospitals to obtain institutional review board approval before implanting the device, a requirement tied to the product's previous Humanitarian Device Exemption status.
