Here are three things to know:
1. The panel voted 10-to-two in favor of the safety of the implant for the treatment of osteoarthritis at the base of the great toe. It also voted nine to three in favor of the efficacy of the implant and eight-to-two, with two abstentions, that the benefits outweighed the risks.
2. The FDA is not bound by the panel’s recommendation, but will take it into consideration when reviewing Cartiva’s premarket approval application.
3. If approved, the Cartiva SCI will be the first synthetic cartilage device ever approved by the FDA.
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