The NUsurface Meniscus Implant has been granted a Breakthrough Device Designation from the US Food and Drug Administration, Active Implants LLC, announces.
The NUsurface Meniscus Implant is the first “artificial meniscus” to be marketed in Europe and, if cleared by the FDA, would be the first artificial meniscus in the US, according to the company, in a media release.
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 US orthopedic market,” says Ted Davis, president and CEO of Active Implants.
“We believe we will have the data required for our FDA submission next year, after completing enrollment in our clinical trials in 2018. 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.”
Elliott Hershman, MD, practicing orthopedic surgeon and medical director for the NUsurface clinical trials, states that, “This will be significant for this patient population, who often don’t have good treatment options. I’m pleased to hear the FDA will prioritize its review of this important new device and possibly make this therapy available for use by other knee surgeons for their American patients.”
[Source(s): Active Implants LLC, Business Wire]