First & #039;Artificial Meniscus & #039; 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 t...
Source: MDDI - Category: Medical Devices Authors: Tags: Orthopedics Source Type: news