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Cartiva Inc. receives FDA premarket approval for synthetic cartilage implant

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Cartiva Inc. has received premarket approval from the FDA for its Cartiva Synthetic Cartilage Implant for treatment of arthritis in the big toe joint.

The Cartiva Synthetic Cartilage Implant (SCI) device is a biocompatible, biomedical polymer implant designed to have physical properties similar to those of articular cartilage, according to a company press release. The Cartiva SCI implant replaces damaged cartilage and provides a cartilage-like compressible, low-friction and durable bearing surface. The implant also improves function and motion and provides pain relief.

According to a company press release, the FDA decision was supported by the MOTION clinical study, a 236-patient, multicenter, prospective, randomized study that compared Cartiva SCI to fusion. Key findings of the study included that patients in the Cartiva group had clinical success of 80% for pain, function and safety at 24 months compared to 79% success for patients in the fusion group.

Reference:

http://cartiva.net/cartiva-announces-fda-premarket-approval-for-cartiva-synthetic-cartilage-implant.html