Breakthrough FDA Approval for ACL Tears to be Healed Instead of Being Rebuilt

The U.S. Food and Drug Administration recently granted marketing authorization for an anterior cruciate ligament (ACL) implant, intended to perform as an alternative to traditional ACL reconstructions. The Bridge-Enhanced ACL Repair (BEAR) Implant, by Miach Orthopaedics, differs from the traditional surgical reconstruction as it does not require the use of harvested tendons for ACL repair but rather helps the tendon to rebuild itself. 

When is an ACL reconstruction necessary?

The knee is the most susceptible joint in the human body to pressure and injury, as its bending capacity is a result of complex interactions of rotational and extensional movements. The anterior and posterior cruciate ligaments (ACL/PCL) connect the bones that form the knee, stabilizing joint movements and preventing the femur from sliding against the tibia and vice versa. Athletes who participate in high contact sports like soccer, football, and basketball, are more likely to injure their anterior cruciate ligaments due to the physical impact of the sport or its eventual wear over time.

ACL injuries affect between 100,000 to 200,000 people in the U.S. each year. The injury does not heal on its own, so ACL reconstruction is the only way to repair it. Many patients never regain their full level of physical activity, even after the procedure. 

The Innovative ACL Repair surgery – BEAR?

The Bridge-Enhanced ACL Repair (BEAR) Implant is promoted as an alternative to the traditional ACL reconstructive surgery. The implant is a resorbable implant meaning that it can be fully absorbed by the body. It’s made from cow tissue that has gone through a purifying and cleaning process. The final product is called an extracellular matrix, which is pure collagen with some other proteins in it. 

With sutures attaching to the torn ends of the tendon, it acts as a bridge between a patient’s ACL. The patient’s blood is then injected into the implant during the surgical implantation procedure with the intent of forming a device-protected clot, thereby enabling the body’s healing process. After about eight weeks, the body’s tissue eventually replaces the implant and the tendon is healed. 

The implant is aimed at patients at least 14 years of age who have a complete ACL rupture confirmed through a magnetic resonance imaging (MRI) scan. The patient must have some tissue intact after the tear for the implant to work. As it stands, implant recipients shouldn’t return to a sport for nine months after their surgery, which is comparable to the traditional ACL reconstruction. 

Approval of the BEAR Implant was based on data from the BEAR II clinical trial, showing non inferiority of the implant to ACL reconstruction in 14- to 35-year-old patients. At two years, average performance scores were 88.6 and 84.6 in the BEAR Implant and control groups, respectively.

Advantages of the new treatment of ACL injury

By using the BEAR implant, no other structures in the body need to be compromised to harvest a graft to replace the injured ligament. This way if the repair does fail, it is much easier to fix than when a graft fails. 

Additionally, having a repaired tendon essentially returning to its natural state avoids problems that can result from reconstructive repairs. Sometimes the placement of the tendon isn’t anatomically correct and the knee could never feel like it had pre-injury. 

ACL/PCL Reconstruction Market Analysis and Forecast

Currently, one of the biggest market limiters is the fact that the demand for donor’s tendons far exceeds the supply of available allografts. As noted by industry participants, the availability of donated tendons is not guaranteed. The use of allografts is also limited, due to the general complexity of processing the donor tissue, mixed with restrictions on the donor age and the graft sizes, varying case by case. However, BEAR will enable surgeons to operate on patients without having to worry about a limited supply of tendons. 

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In 2020, the total ACL/PCL Reconstruction market size was valued at over $260 million. The market is expected to grow to $359 million by 2026. ACL tears are not only linked to the professional sports industry; a 2019 study reported an increase in the ACL tear incidence among pediatric patients over the last 20 years. 

In a statement, Martha Shadan, president and CEO of Miach Orthopaedics, said the implant represented the first substantial advancement in the treatment of ACL tears in decades. She said it had the “potential to change the standard of care.”

Via: U.S. FDA

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