First 'Artificial Meniscus' Wins FDA Breakthrough Device Designation

U.S. patients who continue to suffer from knee pain after meniscus surgery, but are too young for total knee replacement may soon have a new treatment option. FDA has granted Active Implants’ NUsurface meniscus implant a breakthrough device designation.
The artificial meniscus device is already available in Europe and, if cleared by FDA, would also be the first artificial meniscus in the United States.
Earlier this year Active Implants gained some attention from Needham & Co.’s Mike Matson, who included the company on a list of interesting private medtech companies.
“Active Implants has commercialized two unique orthopedic implants in Europe with a visible pathway to bring them into the U.S.,” Matson noted in his June 2019 report. “In particular, it [is] seeking FDA approval of its NUsurface meniscus implant which is the first ‘artificial meniscus’ and intended to fill the gap between minimally invasive meniscus repair and total knee replacement.”
Ted Davis, president and CEO of Memphis, TN-based Active Implants, said the company expects to have the data required for an FDA submission next year.
The NUsurface meniscus implant is designed for patients 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 NUsurface Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. The device is currently marketed in Belgium, Germany, Italy, and Israel.
“The breakthrough device designation is a significant step in our mission to fulfill a substantial unmet need in the U.S. orthopedic market,” Davis said.
FDA’s 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. The agency has been rapidly accepting devices into this pathway this year. Recent breakthrough device designations include a drug-eluting balloon for below-the-knee peripheral artery disease as well as a drug-coated balloon catheter for the same indication from Concept Medical, an interatrial shunt for heart failure from V-Wave, B. Braun’s drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis, a coronary intravascular lithotripsy catheter from Shockwave Medical, a clot ingestion system from Perfuze, and two cancer diagnostic tests.

Original Article: (https://www.mddionline.com/first-artificial-meniscus-wins-fda-breakthrough-device-designation)