Active Implants has announced that the NUsurface Meniscus implant has been granted a Breakthrough Device Designation from the FDA. A press release reports that 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 USA.

The NUsurface Meniscus implant is an investigational treatment for patients in the USA with persistent knee pain following medial meniscus surgery. It is made from medical grade polymer and, as a result of its unique materials, composite structure and design, 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. The NUsurface implant is currently marketed in Belgium, Germany, Italy and Israel.

Ted Davis, president and CEO of Active Implants, says: “The Breakthrough Device Designation is a significant step in our mission to fulfil a substantial unmet need in the US 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.”