The BEAR® Implant is indicated for skeletally-mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI.
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The BEAR ® (Bridge-Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. Food & Drug Administration through the De Novo Pathway in December 2020 for the following indication:
#Surgery for acl trial
Listen to this podcast to hear about the development of the BEAR Implant and clinical trial results. The BEAR Implant does not require a second surgical wound site to remove a healthy tendon from another part of the leg or using a deceased donor’s tendon that requires special storage and handling requirements. The proprietary, bio-engineered BEAR Implant facilitates healing of the torn ACL and has several benefits over ACL reconstruction: It restores natural anatomy and function of the knee, is less invasive and has better patient satisfaction in terms of readiness to return to sport and one-year pain and symptoms. As the ACL heals, the BEAR Implant is absorbed by the body, within approximately eight weeks. The combination of the BEAR Implant and the patient’s blood enables the body to heal the torn ends of the ACL back together while maintaining the ACL’s original attachments to the femur and tibia. The surgeon injects a small amount of the patient’s own blood into the implant and inserts it between the torn ends of the ACL in a minimally invasive procedure.
The BEAR Implant acts as a bridge between the two ends of the torn ACL. Unlike reconstruction, which is the current standard of care, the BEAR Implant does not require a second surgical wound site to remove a healthy tendon from another part of the leg or using a deceased donor’s tendon. The Bridge-Enhanced ® ACL Restoration (BEAR ®) Implant is a proprietary bio-engineered implant used to facilitate healing of the torn ACL. If you are a physician interested in being trained on the BEAR Implant, please complete this form.