US Pharma MarketingThe post FDA approves Artivion’s AMDS device PMA appeared first on Medical Device Network.
FDA approves Artivion’s AMDS device PMA
Artivion has received the PMA clearance from the US FDA for AMDS Hybrid Prosthesis device, permitting its use in treating acute DeBakey Type I aortic dissections with clinical or radiographic malperfusion. The approval was based on data from the PERSEVERE US IDE trial, which included 93 participants. The AMDS Hybrid Prosthesis is designed as an aortic arch remodelling device, used alongside hemiarch replacement surgery. Credit: MAD.vertise/Shutterstock.com. 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…
Artivion has received the PMA clearance from the US FDA for AMDS Hybrid Prosthesis device, permitting its use in treating acute DeBakey Type I aortic dissections with clinical or radiographic malperfusion.
Source: Medical Device Network