July 2016

FDA gives Cartiva implant premarket OK

Alpharetta, GA-based Cartiva reported in July that the Food and Drug Administration (FDA) has given premarket approval to its biocompatible cartilage implant designed to treat hallux rigidus. The FDA based its preliminary approval of Cartiva SCI (synthetic cartilage implant) on results from a 236-person randomized clinical trial comparing the implant with fusion; after two years the success rates for the implant  and fusion were 80% and 79%, respectively, for the composite endpoint of pain, function, and safety.

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