BEAR Implant for ACL Tears

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source: freepik

Miach Orthopaedics has announced the commercial availability of its Bridge-Enhanced ACL Repair (BEAR) Implant for treatment of ACL tears.

The anterior cruciate ligament (ACL) is a band of tissue that connects the thigh bone to the shin. It helps stabilize the knee by preventing forward movement of the shin on the thigh bone. ACL tears are one of the most common sports injuries; if not treated properly, can lead to reduced range of motion and other complications later on. Currently, ACL reconstruction is the only available surgical option for the injury. However, the procedure is highly invasive and requires bones and tissue grafts from either a donor or the person themself. Therefore, researchers hope to provide an alternative with the Bridge-Enhanced ACL Repair (BEAR) Implant.

Developed by Miach Orthopaedics, the BEAR implant acts as a bridge between the torn ends of the ACL. The resorbable implant, made using bovine collagen, is sutured between the torn ends and the patient’s own blood is injected into the implant. Thus, forming a device-protected clot that enables healing of the ACL tear. Eventually, as the ACL heals, the body absorbs the implant and replaces it with new tissue. Unlike surgical repair, it does not require a graft; thus, removing the need of a second wound site and reducing risk of infection. Moreover, it results in a faster recovery of muscle strength than ACL reconstruction.

FDA Approval

In a recent press release, Miach Orthopaedics announced the commercial availability of its BEAR implant in the United States. The implant received a U.S. Food and Drug Administration (FDA) approval in December 2020. FDA’s approval was based on the results of a clinical trial comprising 100 patients with complete ACL rupture. As part of the study, 65 patients received the implant while the control group received ACL reconstruction with an autograft. At the two-year mark, those that received the implant scored higher on the International Knee Documentation Committee Subjective Score. The study further reported an increased laxity, or looseness, of the treated knee among the implant group.

This is the first FDA-approved implant to clinically demonstrate that it enables healing of the patient’s native torn ACL while maintaining the natural knee anatomy.

– DR. JONATHAN L. GLASHOW

Currently, the implant is only indicated for skeletally mature patients, at least 14 years and above, with a complete ACL rupture. Patients must have an ACL stump attached to the tibia for the implant to help restoration. Moreover, the implant device needs to be implanted within 50 days of injury.

Source: Miach Orthopaedics

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