Previously the implant had De Novo Approval to treat skeletally mature ACL tear patients who were at least 14 years or older, according to a March 10 news release. Expanded approval for children is expected to help younger patients heal from ACL tears in a more natural way since the implant uses a patient’s own blood to support healing.
More than 5,000 patients have been treated with the BEAR implant through clinical trial and commercial use.
