The first “artificial” meniscus implant made of a medical-grade polymer to be marketed in Europe has been granted a Breakthrough Device Designation by FDA. If cleared by the agency, which the manufacturer Active Implants LLC hopes to achieve within the next couple of years, it would be a first for a product of this type to come to market in the United States.
The NUsurface meniscus implant is designed 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, said the company in a news release.
The company did not disclose the polymer used in the fabrication of the artificial meniscus but noted that as a result of its unique materials, composite structure and design, the implant does not require fixation to bone or soft tissues. The NUsurface implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint, according to Active Implants.
The FDA Breakthrough Devices Program was implemented to expedite the development and review process for medical devices that are novel or offer new technology for patients with life-threatening or irreversibly debilitating conditions. This program is designed to ensure patients and healthcare providers have more timely access to vital devices.
“The Breakthrough Device Designation is a significant step in our mission to fulfill a substantial unmet need in the U.S. orthopedic market,” said Ted Davis, President and CEO of Active Implants. The company anticipates having compiled sufficient data required for an FDA submission next year, after completing enrollment in clinical trials in 2018. “We look forward to working closely with the FDA to expedite the review process for the NUsurface implant,” added Davis.
Current treatment for a damaged or torn meniscus, a tissue pad between the thigh and shin bones, includes pain management, physical therapy, injections, repair techniques or meniscectomy. Active Implants estimates that as many as one million partial meniscectomies are performed annually in the United States in an attempt to alleviate pain. “However, 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," said the company, citing a paper published in the peer-reviewed Journal of Bone and Joint Surgery.
Active Implants LLC is a privately held company headquartered in Memphis, TN. It operates R&D facilities in Netanya, Israel, and has an EU office in Haarlem, Netherlands. The NUsurface implant is currently available in Belgium, German, Italy and Israel.