Active Implants said yesterday that it won breakthrough device designation from the FDA for its NUsurface meniscus implant, the first of its kind to be marketed in Europe and, if cleared by the FDA, the first artificial meniscus in the U.S.
Memphis-based Active Implants’ NUsurface implant is an investigational treatment for patients suffering from persistent knee pain after medial meniscus surgery.
The implant is made from medical-grade polymer and is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint without a need for fixation to bone or soft tissues.
“The breakthrough device designation is a significant step in our mission to fulfill a substantial unmet need in the U.S. orthopedic market,” CEO Ted Davis said in prepared remarks. “We believe we will have the data required for our FDA submission next year, after completing enrollment 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.”
“This will be significant for this patient population, who often don’t have good treatment options,” added NUsurface clinical drial medical director Dr. Elliott Hershman. “I’m pleased to hear the FDA will prioritize its review of this important new device and possibly make this therapy available for use by other knee surgeons for their American patients.”
NUsurface is currently marketed in Belgium, Germany, Italy and Israel.