FDA Approves Cartiva Synthetic Cartilage Implant (ODTMag)
Cartiva is the first PMA approved alternative to fusion for arthritis of the big toe joint.
Cartiva Inc. announced today that it received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for its Cartiva Synthetic Cartilage Implant (SCI) for arthritis of the big toe joint. The approval allows the Company to begin marketing in the United States the first synthetic cartilage device approved 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 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 this condition.
To read the full feature, see it at ODTmag – FDA Approves Cartiva Synthetic Cartilage Implant
