FDA panel backs InFUSE bone graft for spinal fusion
This article was originally published in Clinica
An FDA advisory panel has unanimously recommended that the agency approve for marketing what promises to be a breakthrough product, a genetically-engineered protein that has been under development for three decades to spur bone growth. If the agency goes along with the endorsement, Medtronic Sofamor Danek's InFUSE bone graft for use in spinal fusion procedures could represent the first major clinical use of a bone growth factor to be widely available to patients. Another bone growth protein, Stryker's OP-1, is only available via a limited humanitarian device exemption for treating recalcitrant long bone nonunions.