INFUSE Review Leads To Discussion And Some Discord At NASS
Medtronic’s subdued showing at NASS in October revealed the sometimes rocky relationship among industry, clinicians, and academia: The Yale University Open Data Access Project suggested rhBMP-2 didn’t fuse bone any better than standard-iliac crest bone graft, yet Medtronic executives found some vindication in the process, saying it supported on-label use of BMP, and suggested the Yale University-led process could be a model to settle future controversies in the medical industry.
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The firm’s bare-bones booth at the North American Spine Society annual meeting was a conspicuous sign of strains between Medtronic and the clinical group over how issues surrounding its rhBMP-2 Infuse bone graft have been presented.
Two independent analyses published on Medtronic’s Infuse biologic bone graft do not paint a positive picture for the device, but they do represent an important model for the future of open-access data analysis for drugs and devices, both Medtronic and academic proponents say.
The long-awaited independent analysis of clinical data on Medtronic’s InFuse recombinant human bone morphogenetic protein-2 (rhBMP-2) found no advantages to using it as a substitute for traditional bone grafts in spinal fusion surgery, while also revealing that the risks of rhBMP-2 may be greater than has been previously reported.