乌鸦传媒視頻

WASHINGTON -- Patients needing reconstruction of torn anterior cruciate ligaments (ACLs) no longer have to rely on grafts harvested from their own bodies or cadavers, with the FDA's on Wednesday.

Called the Bridge-Enhanced ACL Repair (BEAR) Implant, the product is made from bovine collagen and is intended to "bridge the gap between the torn ends" of a completely ruptured ACL. The surgeon secures it with sutures and injects the patient's own blood into the implant during the procedure, which forms a clot that enables ligament healing. The implant itself is resorbed in about 8 weeks, the FDA said.

The device is made by and is indicated for "skeletally mature" patients, ages 14 or older, with MRI-confirmed complete ACL rupture. "Patients must have an ACL stump attached to the tibia to construct the repair," the FDA noted.

A 100-patient clinical trial established the implant's effectiveness, according to the agency, in which 65 received the implant and 35 underwent conventional autograft reconstruction; both groups also received physical therapy. After 2 years, outcomes were similar for pain, knee function, and sports activity as assessed by the patient-reported International Knee Documentation Committee Subjective Score. As well, objective arthrometry evaluations at follow-up showed nearly identical results for joint laxity.

"Torn ACLs are among the most common knee injuries in the U.S., but for years, treatment has been limited to ACL reconstruction, which can be quite invasive and typically requires using tendon or a combination of tendon and bone from other parts of the body, or obtained from a tissue bank, to complete the reconstruction," said Capt. Raquel Peat, PhD, MPH, director of the FDA Center for Devices and Radiological Health's Office of Orthopedic Devices, 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."

Authorization was granted under the agency's de novo device review pathway, which means other devices that work similarly can come to market through the 510(k) notification process.

Comment