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Cartiva received FDA Premarket Approval for the Synthetic Cartilage Implant (SCI) to treat arthritis of the great toe, representing what is reported to be the first synthetic cartilage device and the first product in the forefoot to gain FDA approval. Product introduction occurred at the American Orthopaedic Foot and Ankle Society Annual Meeting in July 2016 when the company announced that the first U.S. patient received the implant.
The approval follows a positive review of the device by FDA’s panel in early 2Q16. 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.
SCI represents an alternative to fusion, the current standard of care for this application. The biocompatible, biomedical polymer implant replaces damaged cartilage with a compressible, low-friction, durable bearing surface.
FDA’s action was supported by MOTION, a 236-patient, multi-center, prospective, randomized study comparing Cartiva SCI to fusion.
Key findings from the Level I clinical study included:
•  Cartiva patient group demonstrated clinical success of 80% for the composite primary endpoint (pain, function and safety) at 24 months vs. 79% success for the fusion group
•  Cartiva patients achieved a 93% reduction in median pain
•  Cartiva patients demonstrated a 168% improvement in median function in sporting activities, 65% improvement in activities of daily living
•  Cartiva patients experienced a 26% improvement in range of motion from baseline
SCI is also undergoing a multi-center study evaluating its use in the treatment of first carpometacarpal joint osteoarthritis at the base of the thumb. An oversubscribed Series D financing, with proceeds of $8.5MM, is partially supporting this trial.
SCI has been approved for use ex-U.S. since 2002 and is available in Europe, Canada and Brazil. To date, >4,000 implants have been employed.
Previous BONEZONE articles to help with your regulatory strategy:
Adaptive Designs Provide Clinical Trial Flexibility
Five Steps to Regulatory Strategy Development
The Starting Line: Turning the Corner with a Device Concept
What Does it Take to Innovate?
