WASHINGTON — The FDA approved an anterior cruciate ligament (ACL) implant, the Bridge-Enhanced ACL Repair (BEAR) Implant, as an alternative to allograft, autograft, or suture-only ACL reconstruction procedures in patients 14 years or older with MRI-confirmed complete ACL rupture.
While torn ACLs are one of the most common knee injuries across the U.S., prior to this approval, invasive ACL reconstruction procedures were the only surgical treatments available, Capt. Raquel Peat, PhD, MPH, USPHS, director of the Center for Devices and Radiological Health’s Office of Orthopedic Devices, said in a statement. “Today’s marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year,” he added.
The BEAR Implant, a resorbable implant made of bovine collagen, is attached with sutures to “bridge the gap between the torn ends of a patient’s ACL,” the FDA explained. “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.” Patients must have an ACL stump attached to the tibia for the implant to connect to, the FDA noted.
This approval is based on results from a randomized controlled trial of 100 patients who had complete ACL rupture, 65 of whom received the BEAR Implant and 35 of whom received autograft reconstruction, after which patients received physical therapy and two years of follow-up.
“At the two-year mark, patients who received the BEAR Implant reported an average score of 88.6 and control subjects reported an average score of 84.6 using the International Knee Documentation Committee Subjective Score, a patient-reported outcome measure (questionnaire) that asks questions about symptoms related to pain and stiffness, sports activity, and knee function,” the FDA explained. “The patients also underwent arthrometry, a noninvasive measurement of laxity—or looseness—of the knee joint. Arthrometry measures the difference in laxity between a person’s healthy leg and their injured leg. In arthrometric assessments, measurements below 3 mm… are considered to be normal. At two years, subjects who received the BEAR implant had a laxity that, on average, was greater by 1.7 mm… in the treated knee than that of the untreated knee. At two years, control subjects had a laxity that, on average, was greater by 1.8 mm in the treated knee than that of the untreated knee. Complications observed in the study consisted of graft or repair failure and the need for additional surgical procedures.”
The BEAR Implant was reviewed via the De Novo premarket review pathway, and the FDA created a new regulatory classification that will allow future devices of the same type to go through the 501(k) premarket process.
The BEAR Implant is manufactured by Miach Orthopaedics, Inc.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 725
Topic ID: 88,725,438,730,192,725,925
