WASHINGTON, July 20, 2016 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced today its role in the successful Premarket Approval (PMA) application decision by the U.S. Food and Drug Administration (FDA) to approve Cartiva, Inc.’s Synthetic Cartilage Implant (SCI) for the treatment of osteoarthritis in the first metatarsophalangeal (MTP) joint (the “great” or “big” toe). The Cartiva SCI is the first hydrogel polymer implant to replace a joint articulating surface ever approved by the FDA and the first PMA for any product in the forefoot. This is the ninth successful PMA in which MCRA has assisted a client since 2006, including the only three lower extremity PMAs.
Hollace Rhodes, Director of Orthopedic Regulatory Affairs at MCRA, added, “We were pleased to work with Cartiva’s top notch team to assist in their regulatory efforts and to facilitate a PMA approval in a short post-panel timeframe.”
MCRA was retained in August 2015, following the original PMA submission in May 2015, to work in conjunction with Cartiva on FDA interactions, responses to FDA questions, and preparation for a meeting of the Orthopedic and Rehabilitation Devices Advisory Panel. Following a positive panel vote on the safety and effectiveness of the device on April 20, 2016, the FDA approved the PMA for the Cartiva SCI on July 1, 2016.
“The decision to involve the experts at MCRA was instrumental in keeping the launch of the Cartiva SCI on track with our projections. MCRA worked very well with our internal team and we couldn’t be happier with them,” said Tim Patrick, President and Chief Executive Officer of Cartiva, Inc.
About Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA)
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance. MCRA’s integrated approach of these key value creating initiatives, as well as orthopedic specialization, provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves nearly 450 clients globally.
CONTACT: David Lown, General Manager, 202-552-5800
SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC