Active Implants Receives IDE Approval for NUsurface Meniscus Implant Study

Active Implants LLC has obtained Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration to conduct the VENUS pivotal clinical trial, designed to evaluate the NUsurface meniscus implant in the treatment of early knee osteoarthritis.

VENUS (Verification of the Effectiveness of the NUsurface System) is a prospective, randomized study to demonstrate superiority of the NUsurface meniscus implant compared to the current standard-of-care for patients with persistent knee pain following meniscectomy surgery.

Active Implants chairman and CEO Henry Klyce said clinical studies outside the United States have shown the NUsurface meniscus implant to provide significant pain relief and restore function compared to currently available treatments.

“Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S.,” he said.

The company has been working for the past three years with knee sports medicine surgeons in Belgium, Italy, Israel, The Netherlands, Sweden and Germany to conduct a multi-center trial of the NUsurface meniscus implant.

NUsurface is designed to help relieve knee pain and restore function similar to that of the healthy meniscus. The meniscus implant, which received European and Israeli approvals, is implanted through an arthroscopic approach and a mini-open procedure.

Active Implants LLC is privately held and based in Memphis, Tenn., that develops orthopaedic implants designed to better integrate with the musculoskeletal system’s natural biomechanics. The company maintains offices in Driebergen, The Netherlands and Netanya, Israel.