Active Implants Begins VENUS Trial in U.S.

Memphis, Tenn.-based Active Implants LLC has begun the VENUS (Verification of the Effectiveness of the Nusurface System) trial, and it is now underway at Lenox Hill Hospital in New York City. Lenox Hill Hospital is one of just 10 sites nationwide participating in the VENUS clinical trial to evaluate the company’s investigational meniscus implant for the treatment of persistent knee pain caused by injured or deteriorating meniscus cartilage.

The meniscus is a tissue pad between the thigh and shin bones. Once damaged, the meniscus has a very limited ability to heal. Over 1 million partial meniscectomies to remove or repair a torn meniscus are performed in the United States every year, about the same as the total number of hip and knee replacement surgeries combined. However, many patients still experience persistent knee pain following meniscus surgery.

“There aren’t many options for patients who experience persistent knee pain following meniscus surgery,” said Dr. Elliott Hershman, M.D., chairman of orthopedic surgery at Lenox Hill Hospital. “Damage to the meniscus can lead to arthritis and the need for knee replacement surgery. We hope this study finds that the NUsurface implant alleviates pain in these patients, as well as helps them delay or avoid knee replacement surgery.”

The VENUS study will enroll approximately 130 patients at orthopedic centers in the United States, Europe and Israel. Participants who meet study requirements and agree to enter the trial are randomized to receive either the Nusurface device or non-surgical treatment, which is the current standard of care for patients with persistent knee pain following meniscus surgery. To be eligible for the study, participants must be between the ages of 30 and 75 and have pain after medial meniscus surgery that was performed at least six months ago.

In the United States, the Nusurface meniscus implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. Nusurface is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissue. The Nusurface device mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. It is inserted into the knee joint through a small incision, and patients typically can go home soon after the operation. After surgery, patients undergo a six-week rehabilitation program.

Nusurface has been used clinically in Europe since 2008 and Israel since 2012.