Two patients in Israel were implanted last week with an artificial meniscus, the first times such an operation has taken place locally for commercial, and not experimental, reasons, according to a statement by the US developer of the product on Sunday.
The procedures were performed by two surgeons: on Monday, Dr. Gabriel Agar of the Yitzhak Shamir Medical Center, formerly the Assaf Harofeh Medical Center in central Israel, completed the first commercial case in a public hospital; on Tuesday, Dr. Ron Arbel of the Ramat-Aviv Medical Center treated the first commercial patient in a private clinic, Active Implants LLC.
Until now the implant was only available in Israel as part of clinical trials. The product, called the NUsurface implant, was developed at the US firm’s research and development center in Netanya, Israel, and is made out of polycarbonate urethane, a medical grade plastic.
The meniscus is a tissue pad between the thigh and shin bones; the lateral meniscus is near the outer edge of a knee joint, and a medial meniscus is toward the inside. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, or a partial or total meniscectomy, in which a damaged meniscus is partially or totally removed.
It is 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 undergo a meniscectomy continue to experience pain that impacts their quality of life and can eventually lead to complete knee replacement surgery.
“When you have knee replacement surgery, where the whole joint is replaced” with a mix of metals and plastic, “the recovery period is very long,” said Eran Ganz, VP R&D and the head of the US firm’s Israel operations.
The NUsurface Implant is a medial meniscus replacement implant 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,” Agar said.
“We are talking about patients in the ages from 35 to 65,” Ganz said.
Walking on same day
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 fits into place like a pillow, without requiring fixation to bone or soft tissues, and then mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint, Ganz said.
Once done, patients can start “walking on the same day,” Ganz said.
The implants are already being marketed commercially in Europe and last week’s implants marked the beginning of marketing in Israel after receiving the necessary regulatory approvals, he said.
“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,” Agar said. “Continued pain after repairing meniscus tears is a very common orthopedic problem, and until now, we have not had effective treatment options.”
In the US, the NUsurface Meniscus Implant was recently granted a Breakthrough Device Designation from the Food and Drug Administration, a track meant to expedite the development and review process for medical devices that are new or offer new technology for patients with life-threatening or irreversibly debilitating conditions. The procedure has not yet been cleared by the FDA, however.
“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, in the statement. “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.”
Active Implants develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, aiming to allow patients to maintain or return to an active lifestyle. The US firm is privately held with headquarters in Memphis, Tennessee. It has European offices in Haarlem, The Netherlands, and R&D facilities in Netanya, Israel.