India, June 29 -- Artivion Inc. (AORT), a cardiac and vascular surgery company, on Monday reported receipt of premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for the AMDS Hybrid Prosthesis in the treatment of Debakey Type 1 aortic dissections.
Debakey Type 1 aortic dissections are reported in approximately 6,000 patients every year in the U.S. alone. The incident is usually sudden and can lead to death within 48 hours if not treated immediately by surgery.
The current standard-of-care involves ascending replacement or hemiarch repair, which can treat the primary tear in the aorta, but does not address the remainder of the diseased aorta. This leaves patients at risk for future complications like malperfusion, end...