The meniscus is a tissue pad between the thigh and shin bones. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, meniscal repair or transplantation techniques, or meniscectomy. It has been estimated that over 2 million partial meniscectomies are performed annually worldwide in an attempt to alleviate pain; however, studies have shown that many people who get a meniscectomy continue to experience pain that impacts their quality of life and can eventually lead to knee replacement surgery. Transplant tissue is scarce, and in many countries, there are waiting lists.
“After more than 10 years in clinical trials, it is an exciting time to finally be able to make the NUsurface Implant available to Israeli patients,” Dr. Agar said. “Continued pain after repairing meniscus tears is a very common orthopedic problem, and until now, we have not had effective treatment options.”
The NUsurface Meniscus Implant is inserted into the knee joint through a small incision, and patients typically can go home soon after the operation. The implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. It is made from a medical grade plastic and, as a result of its unique materials and composite structure and design, does not require fixation to bone or soft tissues.
“The NUsurface Implant has been extensively studied in clinical trials in Israel, Europe and the U.S.,” Dr. Arbel said. “The implant is designed for patients who still have persistent knee pain following a meniscus surgery, and it is ideal for those who have exhausted other treatment options but are too young for total knee replacement.”
In the United States, the NUsurface Meniscus Implant was recently granted a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The FDA implemented the new program to expedite the development and review process for medical devices that are novel or offer new technology for patients with life-threatening or irreversibly debilitating conditions.
“Filling the gap in treatment options between minimally invasive meniscus repair and total knee replacement is a large unmet need in the orthopedic market,” said Ted Davis, president and CEO of Active Implants. “The NUsurface Implant was invented and developed in our R&D center in Israel, so for us it is very exciting to finally bring the device to people in Israel.”
The NUsurface Implant is a medial meniscus replacement implant designed for patients with persistent knee pain following medial meniscus surgery, or those that have failed meniscus repair, are not suitable candidates for meniscus allograft transplant, or are too young for partial or total knee replacement. The NUsurface implant is made from polycarbonate-urethane (PCU)— a medical grade plastic. As a result of its materials and composite structure and design, it does not require fixation to bone or soft tissues. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint, protecting the cartilage. The company announced in September that the NUsurface Meniscus Implant has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration. The NUsurface Meniscus Implant is the first “artificial meniscus” to be marketed in Europe and, if cleared by the FDA, would be the first artificial meniscus in the United States. The NUsurface is not yet cleared by FDA.
Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. ActiveImplants is privately held with headquarters in Memphis, Tenn. European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel.
In April 2019 Active Implants was selected as a partner in the MEFISTO Project: (Meniscal functionalised scaffold to prevent knee Osteoarthritis onset after meniscectomy). The goal of the project is to develop two novel solutions to treat meniscus loss as a strategy for preventing the onset of an epidemic of post-meniscectomy knee osteoarthritis (OA) in Europe. The MEFISTO consortium brings a set of highly motivated partners together, chosen specifically for their expertise to advance the project’s iterative approach and impact on novel orthopaedic approaches. Active Implants has been chosen to develop a polymeric implantable drug delivery meniscus implant. The project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 814444 (MEFISTO).