Medical Technology

Now Available for Sale Now Available Commercially: Biologically enhanced ACL Reparation

The anterior Cruciate Ligament (ACL) tears surgeons are now able to make bio-enhanced repairs.

The Bridge-Enhanced ACL Repair (BEAR) implant allows surgeons to repair an ACL using a scaffold bridge that connects the ACL that has been torn and the bone. To aid in healing the scaffolding is constructed of extracellular matrix that is injected with the blood from the patient.

ACL tears are typically treated using reconstruction instead of repair. Because the ACL is located within the joint, it is often impossible to repair the ligament on its own.

The BEAR implant aims to alter the surrounding environment surrounding the ACL so that the ligament can heal itself.

Recent prospective randomized, controlled trial found no difference in results when using the implant compared to ACL reconstruction at two years.

The implant is advised for patients who are at minimum 14 years old and have a complete tear of their ACL. This is an injury that can be corrected with sutures.

Martha Murray, Dr. Martha Murray

Martha Murray, MD is an orthopedic surgeon-in chief at Boston Children’s Hospital. The basis for the BEAR ACL implant was Martha Murray. She is also the creator of Miach Orthopaedics, a privately owned company that was founded to produce and market the BEAR implant

Murray was a graduate student in engineering when she first began to think about alternative options for ACL reconstruction. “A friend of mine had injured his anterior cruciate ligament skiing,” she told Medscape Medical News. “I asked if they were going to stitch it back together, and he laughed and said, ‘You can’t sew the ACL again, they must take the ACL and remove two tendons from the back of my leg and use them to replace the ACL.'” Her first thought was “That can’t be the best solution.”

With the initial research funding provided by the NFL Players Association, Boston Children’s Hospital and the National Institutes of Health (NIH), Murray and her team began to investigate how the ACL heals.

She explained, “The first success was finding that the cells and blood vessels in the ACL were still functioning even after the tissue was torn. However, the synovial environment was hindering healing.” This success was followed by years of frustration trying to find a material that could help create an environment that could heal the torn edges of the ligament.

“Once we had identified the material we were able to demonstrate the idea of bridge-enhanced ACL restoration,” she recalled.

With the recent news that the implant is now commercially available surgeons do not have to be part of clinical trials to perform the bridge-enhanced ACL restoration procedure.

Murray hopes commercialization of the implant will make the procedure more accessible, rather than being available only at Boston Children’s Hospital, where the initial trials were done.

Dr David R. McAllister

David R. McAllister, MD, chief of sports medicine at the David Geffen School of Medicine at UCLA is not involved in the research, but is familiar with the BEAR implant clinical trials that have been published in the orthopedic literature and has been keeping track of the results.

He believes that the early data could have a positive effect on practice, but it’s still too early for him to make a definitive statement. “While their data is very positive,” he said. “Longer-term clinical outcomes for larger numbers of patients is required to better understand this technology.”

In the spectrum of ACL tear treatment options Dr. A.J. isn’t convinced that the average surgeon is willing to accept the notion of biologically enhanced ACL repairs.

He told Medscape Medical News, “I am not sure what the majority of surgeons think about this. In light of the fact that ACL reconstruction is a widely accepted treatment option that has excellent clinical results, it seems that many surgeons — including me — would like to know more evidence before incorporating this into their clinical practices.”

McAllister said that the future research should focus on specific patient populations, specifically young athletes and athletes.

Nicholas Sgaglione MD, professor and chair of Northwell Health System Department of Orthopedic Surgery, New York, is familiarized with the results of the BEAR implant trial. He is awaiting further data before he decides. “I am curious, but skeptical,” he said in an interview with Medscape Medical News.

He believes it is practice-changing, but is concerned that the widespread use may result in increased failures due to the insufficient information. He would also like to see more specific patient populations being studied. He believes that active, older patients are the ideal candidates for this type of technology.

“This is novel and captivating work, but it needs to be able to stand up to greater scrutiny,” Sgaglione said.

Murray hopes that the BEAR implant will be widely used and continue to provide promising results. Murray has stated that she would like to have the BEAR implant provide the best environment for tissues that are injured to speed up healing.

Murray is the founder and an equity shareholder of Miach Orthopaedics, which manufactures and sells the BEAR implant. Murray has received funding from the NIHand the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Translational Research Program at Boston Children’s Hospital as well as the National Football League Players Association to support this research. McAllister and Sgaglione have not disclosed any financial relationships.

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Content Source: https://www.medscape.com/viewarticle/964541?src=rss

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