FDA panel to review Medtronic’s InFuse
This article was originally published in The Gray Sheet
Executive Summary
Bone graft for oral maxillofacial procedures will go before agency's Dental Products Panel Nov. 9 in Gaithersburg, Md., according to the Oct. 26 Federal Register. Infuse contains the recombinant human bone morphogenetic protein rhBMP-2 - a "genetically engineered version of a naturally occurring protein ... capable of initiating bone growth," Medtronic says. InFuse also is being studied under an investigational device exemption for use in cervical spinal fusion (1"The Gray Sheet" Oct. 16, 2006, In Brief)...