FDA Clears Miach’s Anterior Cruciate Ligament Implant
The FDA has granted marketing authorization for Boston-based Miach Orthopaedics’ Bridge-Enhanced ACL Repair (BEAR) implant for repairing torn anterior cruciate ligaments (ACLs).
Unlike traditional reconstruction methods, the resorbable implant does not require the use of harvested tendons and it is the only currently cleared alternative to reconstruction with allograft, autograft or suture-only repair for treating ACL ruptures. The device was cleared through the FDA’s de novo premarket review pathway.
The authorization “provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year,” said Raquel Peat, director of the Center for Devices and Radiological Health’s Office of Orthopedic Devices.