Joint preservation developer Active Implants has been granted Breakthrough Device Designation from the Food and Drug Administration for its NUsurface meniscus implant.
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 U.S.
The FDA Breakthrough Devices Program was implemented 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. This program is designed to ensure patients and healthcare providers have more timely access to vital devices.
Ted Davis, president and CEO of Active Implants said: “The Breakthrough Device Designation is a significant step in our mission to fulfil a substantial unmet need in the U.S. orthopaedic market. We believe we will have the data required for our FDA submission next year, after completing enrolment in our clinical trials in 2018. We look forward to working closely with the FDA to expedite the review process for the NUsurface implant to provide a new treatment option to the hundreds of thousands of patients who continue to experience persistent knee pain following meniscus surgery, but are too young for total knee replacement.”
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, repair techniques or meniscectomy. 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.
The implant is made from medical grade polymer and does not require fixation to bone or soft tissues. It mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint.
Elliot Hershman, practicing orthopedic surgeon and medical director for the NUsurface clinical trials, said: “This will be significant for this patient population, who often don’t have good treatment options. I’m pleased to hear the FDA will prioritise its review of this important new device and possibly make this therapy available for use by other knee surgeons for their American patients.”