In a Safety Communication issued today, the U.S. Food and Drug Administration (FDA) warned that Infuse and other bone graft substitutes containing recombinant proteins or synthetic peptides are not safe for use in patients under age 18.
Infuse and other bone graft substitutes containing recombinant proteins or synthetic peptides are considered high-risk (Class III) medical devices by the FDA. Medtronic and the manufacturers of similar products must submit a premarket approval application (PMA) to the agency that includes clinical data supporting safety and effectiveness, the FDA explained in the Safety Communication. These devices have not been approved for use in people under age 18 and have not been reviewed by federal regulators. More Infuse Should not be Used in Patients Under age 18, the FDA Warns