On December 16, 2020, the FDA announced the market authorization under the De Novo premarket review pathway for a new anterior cruciate ligament (ACL) implant from Miach Orthopaedics, Inc. The company says it is the first new treatment for ACL tears in over 30 years.
The Bridge-Enhanced ACL Repair (BEAR) Implant
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,” according to the FDA press release.
Getting something through the De Novo process is impressive. During a recent Orthopedics This Week Broadcasting event, Janice Hogan, Partner at Hogan Lovells US LLP, told listeners that in 2018, half of all De Novo applications failed to get through the FDA.
Captain Raquel Peat, Ph.D., MPH, USPHS, director of the Center for Devices and Radiological Health’s Office of Orthopedic Devices, noted that treatment of ACL ruptures have been limited to ACL reconstruction which normally require tendons and/or bone from other parts of the body obtained from a tissue to bank. “Today’s marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.”
Resorbable Bovine Collagen Implant
The implant, according to the FDA, is a resorbable implant 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 surgery to form 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 FDA used a randomized controlled trial of 100 subjects with complete ACL rupture to evaluate the implant. In the study, 65 patients got the BEAR Implant and 35 members of the control group received ACL reconstruction with autograft. Patients received physical therapy and were followed for two years.
After those two years, the implant group, on average, beat the control group using the International Knee Documentation Committee Subjective Score, 88.6 to 84.6. The score reflects self-reporting about symptoms related to pain and stiffness, sports activity, and knee function.
The patients also underwent arthrometry, a noninvasive measurement of laxity—or looseness—of the knee joint. It measures the difference in laxity between a person’s healthy leg and their injured leg. At two years, the BEAR implant group had a laxity that, on average, was greater by 1.7mm (about the same as the thickness of a penny) in the treated knee than that of the untreated knee. The control group had a laxity that, on average, was greater by 1.8mm 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.
New Regulatory Classification
Besides beating tough odds for successfully navigating the De Novo process, Miach Orthopaedics is also clearing the way for future devices of this type. A De Novo action, according to the FDA, creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process.
Martha Murray, M.D., founder of Miach Orthopaedics and professor of orthopedic surgery at Boston Children’s Hospital/Harvard Medical School, said there are a number of advantages to repairing a ligament instead of replacing it. “That is why, more than 30 years ago, we set out to find a way to help the ligament heal itself. We’ve been encouraged by the results of the clinical studies at Boston Children’s Hospital showing that repair using a BEAR Implant is a viable alternative to autograft ACL reconstruction. FDA approval validates the decades of work our teams have put into this technology and is truly rewarding.”
The BEAR repair video is available here.
