FDA's Orthopaedic and Rehabilitation Devices Panel recommended premarket approval of Cartiva's Synthetic Cartilage Implant (SCI) for the treatment of osteoarthritis in the great toe.
The panel voted 10 to 2 in favor of safety, 9 to 3 in favor of the efficacy and 8 to 2 (with 2 abstentions) that the benefits outweighed the risks. The panel made recommendations based on the results from MOTION, a 236-patient prospective and randomized clinical trial, the largest-ever study conducted for this condition.
While FDA is not bound by the panel’s recommendation, it will be considered during review of Cartiva's premarket approval application (PMA). Cartiva expects a final decision on approval later in 2016.
If approved, Cartiva SCI will be the first synthetic cartilage device ever approved by FDA and the first PMA for any product in the forefoot.
Should FDA issue premarket approval, the panel advised that 5-year post-approval studies be performed to determine survival rate and observe any other safety issues. Further, the panel recommended strict limitations on the product's indications, such as exclusion of patients with hallux valgus or an unstable joint.
Other trials underway:
In 3Q15, Cartiva announced the first patient treated in GRIP, a multi-center study evaluating the SCI to treat osteoarthritis at the base of the thumb.