Orthopedic implant specialist, Active Implants, LLC, tells us the final patient was treated in the two clinical trials evaluating the NUsurface® Meniscus Implant.
The NUsurface® Meniscus Implant is designed for the treatment of persistent knee pain caused by injured or deteriorated meniscus tissue. The implant is made from medical grade polymer and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. It is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and in Israel since 2011.
If approved by the U.S. FDA, NUsurface® would be the first “artificial meniscus” on the U.S. market. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. It has been estimated that from 700,000 to over 1 million partial meniscectomies are performed annually in the U.S. in an attempt to alleviate pain; however, recent studies have shown that many people who get a meniscectomy continue to experience pain that impacts their quality of life and can eventually lead to knee replacement surgery.
The two trials are being conducted to evaluate the safety and effectiveness of the NUsurface Meniscus Implant in support of U.S. FDA De Novo 510(k) clearance. They have now enrolled a combined 243 patients, 176 of which received the NUsurface Meniscus Implant. The VENUS (Verification of the Effectiveness of the NUsurface System) trial is a randomized, multi-centered, prospective, controlled study comparing the NUsurface implant to the non-surgical standard of care and enrolled 128 patients at 10 U.S. study sites. The SUN (Safety Using NUsurface) trial is a single-arm study assessing the safety and probable benefit of the NUsurface Meniscus Implant in restoring function similar to that of a natural, healthy meniscus and enrolled 115 patients at 13 U.S. study sites.
Active Implants conducted the two different types of studies concurrently in order to bring the NUsurface Meniscus Implant to market as quickly as possible while the company worked with the FDA to finalize the regulatory clearance for marketing in the U.S.
“The NUsurface Implant is being studied in patients who still have persistent knee pain following a meniscus surgery, have exhausted other treatment options, and are too old for repair and too young for total knee replacement,” said Elliott Hershman, MD, orthopedic surgeon at Lenox Hill Hospital in New York City and medical director for the studies.
“We are now one step closer to filling the gap in treatment options between minimally invasive meniscus repair and total knee replacement, which is a large unmet need in the orthopedic market,” said Ted Davis, president and CEO of Active Implants. “With enrollment complete, we will continue to work closely with the FDA and now focus our efforts on collecting the data required for the U.S. regulatory submission. We thank our investigator surgeons and patients for making this day possible.”
Source: Active Implants, LLC