FDA has granted a Breakthrough Device Designation to Active Implants’ NUsurface® Meniscus Implant. Active Implants, LLC develops orthopedic implant solutions for joint preservation. 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 United States.
The FDA Breakthrough Devices Program expedites 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 that 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,” 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.”
“This will be significant for this patient population, who often don’t have good treatment options,” says Elliott Hershman, MD, a practicing orthopedic surgeon and medical director for the NUsurface clinical trials. “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.”
The meniscus is a tissue pad between the thigh and shin bones. 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 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.1
The NUsurface Meniscus Implant is an investigational treatment for patients in the United States with persistent knee pain following medial meniscus surgery. It 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. The implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. It is currently marketed in Belgium, Germany, Italy, and Israel. In the United States, it is an investigational device and is limited by U.S. law to investigational use.
Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, TN. European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel.
For more information, visit here .