Posted by Michael Wonder on 16 Dec 2020
FDA authorises marketing of new implant to repair a torn anterior cruciate ligament
16 December 2020 - Today, the U.S. FDA granted marketing authorisation—under the De Novo premarket review pathway—for an anterior cruciate ligament implant, intended to serve as an alternative to anterior cruciate ligament reconstruction to treat anterior cruciate ligament tears.
The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for anterior cruciate ligament repair and is the only currently- available alternative to reconstruction with allograft, autograft or suture-only repair for the treatment of anterior cruciate ligament rupture.
