The Food and Drug Administration recently granted marketing authorization for an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears. The FDA granted the marketing authorization to Miach Orthopaedics, Inc.

The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently- available alternative to reconstruction with allograft, autograft or suture-only repair for the treatment of ACL rupture.

And the San Diego Union Tribune reports that Jenna Richardson of Oceanside, was the first in the area to choose BEAR over reconstruction after tearing her ACL while mountain biking in July. After reading every study she could find, the medical sales representative said she liked the idea of avoiding the ligament harvesting process which requires an additional incision and increases the amount of rehabilitation necessary after surgery. She also shied away from replacement with tissue from a deceased organ donor after several friends who went that route experienced additional tears.

Dr. Tim Wang, an orthopedic surgeon and sports medicine specialist at Scripps Clinic, performed the procedure on Aug. 22, making Richardson the first patient in San Diego County to undergo BEAR repair. “The early data and research shows that it’s as good as our standard of care with a potential for faster muscle recovery,” Wang said.

The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. Despite being a very common injury, until today, the only surgical treatment available for torn ACLs has been ACL reconstruction using allograft, autograft or suture-only repair.

Professional athletes are likely to continue going the reconstruction route for some time to come, said Dr. Tal David, a San Diego orthopedic surgeon whose practice often includes pro athletes.

As the only other surgeon in the county approved to perform BEAR procedures, David said that it’s difficult to recommend something brand new when a person’s livelihood hangs in the balance and the existing standard yields very good results.

“We’ve done many, many thousands of reconstructions over many years, and the risk of retearing is around 5 percent,” David said. “For professional athletes, I would say it’s about a predictable outcome.”

On the other hand, there are clear advantages to repair. In addition to avoiding a harvesting procedure David said that healing in place may prove better for recovery of the nerves that allow the body to sense knee position.

The BEAR Implant is a resorbable implant – meaning it is absorbed by the body – made from bovine collagen and is secured via suture to bridge the gap between the torn ends of a patient’s ACL. The patient’s own blood is injected into the implant during the surgical implantation procedure with the intent of forming a device-protected clot that enables the body’s healing process. Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the body’s own tissue.

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. Patients must have an ACL stump attached to the tibia to construct the repair.

Dr. Martha Murray’s research on the development of the company’s BEAR® Implant was selected for the 2022 Orthopaedic Research and Education Foundation (OREF) Clinical Research Award. The award for “Bridge-Enhanced ACL Restoration: Translation from Academic Lab to FDA Approval” was presented at the Orthopaedic Research Society Annual Meeting Feb. 6 in Tampa Bay, Florida.