Active Implants receives IDE approval to conduct NUsurface Meniscus Implant trial for knee osteoarthritis

Active Implants, the technology leader in cushion-bearing orthopedics for treatment of osteoarthritis, today announced it has received Investigational Device Exemption (IDE) approval to conduct a pivotal clinical trial of the NUsurface® Meniscus Implant in patients with knee osteoarthritis.

The "VENUS"-study (Verification of the Effectiveness of the NUsurface® System) is a prospective, randomized, multicenter 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.

"Clinical studies outside the USA have shown that the NUsurface® Meniscus Implant results in significant pain relief and restoration of function compared to currently available treatments," said Henry Klyce, Chairman and CEO of Active Implants. "Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S."

Elliott Hershman, M.D. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. Dr. Hershman said, "The NUsurface® Meniscus Implant is a novel, composite polymer implant, which is used to treat knee patients who have pain and disability arising from osteoarthritis caused by a previous meniscectomy, meniscus dysfunction or insufficiency. The NUsurface® Meniscus Implant was designed to meet the needs of patients too old for meniscus repair and too young for a knee replacement."

For the past three years, Active Implants has been working with leading knee sports medicine surgeons in Belgium, Italy, Israel, The Netherlands, Sweden and Germany to conduct a prospective controlled, Multi-Center Trial of the NUsurface® Meniscus Implant. Peter Verdonk, M.D., PhD, an investigator in the Multi-Center trial from Orthopaedic Center Monica Hospitals Antwerp and University of Ghent, Belgium, said, "I am impressed with the results observed to date and believe this technology could represent a new method of treating patients with meniscus problems who are often on a long and painful progression to knee replacement."