FDA authorizes bridge-enhanced ACL repair implant
The FDA has announced marketing authorization, through the de novo premarket review pathway, of a bridge-enhanced ACL repair implant by Miach Orthopaedics Inc.
The implant, known as BEAR, is an alternative to ACL reconstruction, according to a press release.
The BEAR implant is a bovine collagen-based implant that is sutured to the torn ends of a patient’s ACL. It is designed to be reabsorbed by body tissue within 8 weeks.
Seen as an alternative to reconstruction with allograft, autograft or sutures, the implant eliminates the need for harvested tendon or bone.
“Torn ACLs are among the most common knee injuries in the U.S., but for years, treatment has been limited to ACL reconstruction, which can be quite invasive and typically requires using tendon or a combination of tendon and bone from other parts of the body, or obtained from a tissue bank, to complete the reconstruction,” Capt. Raquel Peat, PhD, MPH, USPHS, director of the Center for Devices and Radiological Health’s office of orthopedic devices, said in the release. “Today’s marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year,” she added.