Synthetic Cartilage, Bioelectronic Device To Ease The Pain Of Arthritis, Cartiva Reveals
Novel medical device technologies – the first synthetic cartilage implant approved by FDA and a bioelectronic implant to stimulate the vagus nerve – present new approaches to treating arthritic pain.
Cartiva's Synthetic Cartilage Implant (SCI) has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) as the first synthetic cartilage device ever, and the first indicated for painful arthritis at the base of the great toe. The Orthopaedic and Rehabilitation Devices Panel convened by FDA in April voted 10-to-two in favor of the safety of SCI, nine-to-three in favor of its efficacy, and eight-to-two, with two abstentions, that the benefits outweighed the risks.
Cartiva's Synthetic Cartilage Implant (SCI) has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) as the first synthetic cartilage device ever, and the first indicated for painful arthritis at the base of the great toe. The Orthopaedic and Rehabilitation Devices Panel convened by FDA in April voted 10-to-two in favor of the safety of SCI, nine-to-three in favor of its efficacy, and eight-to-two, with two abstentions, that the benefits outweighed the risks.