Cartiva said today that it won pre-market approval from the FDA for an implant designed to treat arthritis in the big toe.
Alpharetta, Ga.-based Cartiva said the device is the 1st synthetic cartilage implant approved for the U.S. market. It’s meant as an alternative to the standard of care, a fusion procedure using screws and plates. The Cartiva SCI is made of a biocompatible polymer with similar physical properties to human cartilage.
“We are thrilled with the approval of Cartiva SCI and appreciate the hard work and collaboration of the U.S. Food and Drug Administration orthopedic branch. We’re grateful to our clinical investigators, their study coordinators and, of course, our patients in helping us reach this critical milestone,” president & CEO Tim Patrick said in prepared remarks. “We look forward to introducing Cartiva SCI at the American Orthopaedic Foot & Ankle Society Annual Meeting in Toronto later this month.”
“The landmark Motion study clearly shows Cartiva SCI to be a safe and effective alternative to fusion for patients wishing to maintain motion in their great toe,” added principal investigator Dr. Judith Baumhauer of the University of Rochester Medical Center. “Based on these compelling results, I have eagerly awaited the FDA approval and the ability to offer this treatment option to my patients.”
Cartiva SCI won CE Mark approval in the European Union back in 2002 and is on the market there and in Canada and Brazil, the company said.