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)...
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Firm will conduct a trial of its InFuse bone graft in cervical spinal fusion after being granted an investigational device exemption from FDA, Medtronic announces Oct. 13. The bone graft will be used inside a polyetheretherketone (PEEK) polymer interbody spacer with a cervical plate. According to Medtronic, 200,000 spinal fusion procedures for the cervical spine are conducted in the U.S. each year. InFuse is approved to treat open tibia fractures and for anterior lumbar interbody fusion procedures. The firm also is pursuing approval for InFuse in posterior lumbar fusion and oral maxillofacial procedures...
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