Active Implants was granted a Breakthrough Device Designation from FDA for the NUsurface® Meniscus Implant. NUsurface is the first artificial meniscus to be marketed in Europe and, if cleared by FDA, would be the first artificial meniscus in the U.S.
FDA's Breakthrough Devices Program was created to expedite the development and review process for medical devices that are novel, or that offer new technology for patients with life-threatening or irreversibly debilitating conditions. It is designed to ensure that patients and healthcare providers have timely access to vital devices.
The polymer NUsurface device is an investigational treatment in the U.S. for patients with persistent knee pain following medial meniscus surgery. As a result of its materials, composite structure and design, it does not require fixation to bone or soft tissue. The implant mimics the function of the natural meniscus and redistributes loads across the knee joint. NUsurface has been used in Europe under the CE Mark since 2008 and in Israel since 2011.
Two trials assessing the device enrolled a combined 243 patients, 176 of which received NUsurface. VENUS (Verification of the Effectiveness of the NUsurface System) commenced in 2015 as a randomized, prospective, controlled study comparing NUsurface to non-surgical care, enrolling 128 patients at 10 U.S. sites. SUN (Safety Using NUsurface) followed in 2016 as a single-arm study assessing the restoration of function similar to a healthy meniscus, enrolling 115 patients at 13 U.S. sites.
“We believe we will have the data required for our FDA submission next year, after completing enrollment in our clinical trials in 2018," said Ted Davis, President and CEO. "We look forward to working closely with the FDA to expedite the review process for the NUsurface® Implant to provide a new treatment option to the hundreds of thousands of patients who continue to experience persistent knee pain following meniscus surgery, but are too young for total knee replacement.”