Active Implants has obtained Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) 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 that clinical studies outside the US have shown that the NUsurface meniscus implant results in significant pain relief and restoration of function compared to currently available treatments.
"Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the US," Klyce added.
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.