Cartiva touted 5-year data for its synthetic cartilage implant in patients with arthritis at the base of the big toe. The data, which included results from 27 patients, were published in Foot and Ankle International.
The study found that patients experienced a 91% mean reduction in pain after 5 years and a 128% mean improvement in sporting activities, according to Cartiva. Patients also experienced a 42% improvement in range of motion, the company said, and a high level of satisfaction with the treatment.
The company’s implant is a biocompatible polymer designed to have physical characteristics similar to articular cartilage. It was developed as an alternative to the standard of care, which is traditionally a fusion procedure using screws and plates
“These clinical results are consistent with what I have seen in my own practice. Pain and functional outcomes improved significantly, and 96% of the patients said they would choose to undergo the procedure again,” lead author Dr. Timothy Daniels said in prepared remarks.
Cartiva won 510(k) clearance from the FDA for its implant in July last year, making it the 1st synthetic cartilage device approved by the federal watchdog.
“Cartiva SCI has been used commercially outside the United States for nearly 15 years, and publication of its long-term durability in this prestigious, peer-reviewed journal is another key milestone,” president & CEO Tim Patrick added. “We will continue adding to the unparalleled, Level 1 clinical evidence of Cartiva SCI as a motion-preserving alternative to joint fusion.”