The U.S. Food and Drug Administration has granted Premarket Approval to Cartiva, Inc. for its Cartiva Synthetic Cartilage Implant (SCI), which is designed to treat arthritis at the base of the big toe, the most common arthritic condition in the foot.
The approval allows the company to begin marketing in the United States the first synthetic cartilage device approved by the FDA. 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, according to the company.
The 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 and durable bearing surface. The implant provides pain relief and improves both function and motion.
The FDA’s decision was supported by the MOTION clinical study, a 236-patient, multi-center, prospective, randomized study comparing Cartiva SCI to fusion — the largest study ever conducted for the condition.
Key findings from the Level I clinical study include:
- The Cartiva patients demonstrated clinical success of 80 percent for the composite primary endpoint (pain, function and safety) at 24 months compared to 79 percent success for the fusion group
- Patients achieved a 93 percent reduction in median pain
- The demonstrated a 168 percent improvement in median function of sporting activities and 65 percent improvement in activities of daily living
- The patients experienced a 26 percent 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 performed in a simple outpatient procedure lasting approximately 35 minutes. Unlike a fusion procedure, patients may begin weight bearing immediately as tolerated.
Based in Alpharetta, GA, Cartiva, Inc. develops and markets products for patients with cartilage damage and osteoarthritis.