Active Implants announced it has received Investigational Device Exemption approval from the U.S. Food and Drug Administration to conduct a clinical trial of the NUsurface Meniscus Implant in patients with knee osteoarthritis.
The NUsurface Meniscus Implant is intended to help relieve knee pain and restore function similar to that of the healthy meniscus. The prospective, randomized, multicenter study will investigate the efficacy of the implant compared to the current standard-of-care for patients with persistent knee pain following meniscectomy surgery.
"Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S." said Henry Klyce, chairman and CEO of Active Implants, in a news release.
Active Implants is a developer of cushion-bearing orthopedic devices for the treatment of osteoarthritis.
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