FDA OKs Synthetic Implant for Repairing ACL Tears
OrthoBuzz has been following the development of the Bridge-Enhanced ACL Repair (BEAR) implant—a synthetic alternative to graft-based anterior cruciate ligament reconstruction—since 2015 (see previous OrthoBuzz posts). On December 16, 2020 the FDA granted authorization to Miach Orthopaedics, Inc. to market the implant.
The BEAR implant is made from bovine collagen. After securing it with sutures to the torn ends of a completely ruptured ACL, the surgeon injects the patient’s own blood into the implant, which forms a clot that enhances ligament healing. Within 8 weeks, the implant is resorbed and replaced by the body’s own tissue.
The FDA’s authorization was based on results from a 100-patient randomized clinical trial, in which 65 patients received the BEAR implant and 35 underwent conventional autograft reconstruction. After 2 years, patient-reported outcomes in both groups were similar for pain, knee function, and sports activity, and arthrometry showed nearly identical joint-laxity outcomes. It remains to be seen how durable the BEAR implant will be over time and how much arthritis will develop in BEAR-treated knees 15 or 20 years from now.
The FDA’s marketing authorization for the BEAR implant was granted under the agency’s de novo device review pathway. That means that subsequent similar devices can be reviewed through the FDA’s 510(k) process, which requires a demonstration of “substantial equivalence” to the predicate device.