An FDA panel has overwhelmingly voted to recommend approval of the Cartiva Inc.'s Cartiva synthetic cartilage toe implant despite strong reservations that the firm's data is relatively weak.
On April 20, the FDA's Orthopaedic and Rehabilitation Devices Panel voted 8-2 with two abstentions that the benefits of the implant outweigh the risks. The device, made from an organic polymer-based biomaterial comprised of polyvinyl alcohol and saline, would be the first of its kind to treat osteoarthritis in the greater toe