In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers and regulatory and quality experts, and adds additional expertise with FDA submissions. The author of this post is a member of this team, which has done significant work with novel and/or high-risk devices focusing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests and Safer Technology Program Requests. 

Chances are pretty good you have heard of the anterior cruciate ligament, or ACL, one of a pair of cruciate ligaments in the human knee. Also likely is that you or someone you know has injured or torn their ACL, given that over 400,000 ACL injuries occur in the U.S. each year…ouch! Your ACL is composed of strong, fibrous tissue that connects the femur and tibia. This important ligament controls excessive motion of the joint by limiting mobility. Most ACL tears are not caused by running into something or someone, but rather result from a non-contact event such as a sudden change in a direction that causes the knee to rotate inward. Stopping suddenly, landing awkwardly, and pivoting or twisting with a foot firmly planted can cause a strain or tear of the ACL. ACL injuries are often associated with sports such as soccer, basketball, football and downhill skiing as they involve sudden stops or changes in direction, jumping and landing.

When an ACL tear occurs, many people describe hearing a “pop” in their knee, followed by swelling, pain, and a feeling of being unstable or unable to bear weight. Depending on the severity of the injury, treatment may involve rest and rehabilitation exercises to help regain strength and stability, or ACL reconstruction surgery to replace the torn ligament followed by rehabilitation.

To date, surgery for a torn ACL often involves removing the torn ligament and replacing it with a piece of a tendon from another part of the knee (aka a graft) or from a deceased donor (aka an allograft). However, a new surgical option has just been authorized by FDA. On December 16th, FDA granted marketing authorization to Miach Orthopaedics, Inc. for the Bridge-Enhanced ACL Repair (BEAR) Implant, which does not require the use of harvested tendons for ACL repair and is the only currently-available alternative to ACL reconstruction.

The BEAR Implant is a resorbable implant - meaning it is absorbed by the body - made from bovine collagen that 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, the device is absorbed and replaced by the body’s own tissue. SO cool!

The FDA reviewed the BEAR Implant through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. As part of the De Novo process, FDA established special controls for devices of this type, including requirements related to labeling and performance testing. These special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. FDA also generated a new regulatory classification, which means that subsequent devices of the same type and with the same intended use may go through the FDA’s 510(k) premarket notification process.

In the FDA press release, Capt. Raquel Peat, Ph.D., MPH, USPHS, director of the Center for Devices and Radiological Health’s Office of Orthopedic Devices, noted that “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. Today’s marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.” 

We at AcKnowledge RS find this new technology and its regulatory pathway very exciting. As always, while we hope you never have need for the BEAR Implant, it is wonderful that an additional option is now available to surgically repair an individual’s own torn ACL!

Further Reading

  1. Video - How BEAR Implant Works

  2. Miach Orthopaedics

  3. FDA Press Release

  4. De Novo Classification Request

  5. ACL Injury - Mayo Clinic

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