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FDA Approves First Synthetic Cartilage Implant
Cartiva, Inc., has received premarket approval from the FDA for its Cartiva Synthetic Cartilage Implant (SCI) for arthritis of the big toe joint. The approval allows the company to begin U.S. marketing of the first synthetic cartilage device cleared by the FDA.
Cartiva SCI is intended for the treatment of painful arthritis at the base of the big toe, the most common arthritic condition in the foot. The current standard of care involves fusing the bones in the arthritic joint with screws and plates. While fusion is an effective procedure for eliminating pain, it permanently prevents movement of the joint.
The Cartiva SCI device, an alternative to fusion, is a biocompatible, biomedical polymer implant designed to have physical properties similar to those of articular cartilage. Damaged cartilage is replaced with a small Cartiva SCI implant that provides a cartilage-like compressible, low-friction, durable bearing surface. The implant provides pain relief and improves both function and motion, according to Cartiva.
The FDA’s decision was based on data from the MOTION trial, a multicenter, prospective, randomized study comparing Cartiva SCI with fusion in 236 patients. In this study, the Cartiva-treated patients demonstrated:
- A clinical success rate of 80% for the composite primary endpoint (pain, function, and safety) at 24 months compared with a 79% success rate for the fusion group
- A 93% reduction in median pain
- A 168% improvement in median function of sporting activities
- A 65% improvement in activities of daily living
- A 26% improvement in range of motion from baseline
Cartiva SCI has been approved for use outside the United States since 2002 and is currently available in Europe, Canada, and Brazil. To date, more than 4,000 implants have been used. It is implanted in a simple outpatient procedure lasting approximately 35 minutes. Unlike a fusion procedure, patients may begin weight-bearing activity immediately as tolerated.
Source: Cartiva; July 5, 2016.