No Advantage For Medtronic’s InFuse Versus Bone Graft In Spine Fusion
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.
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Two independent analyses published last week 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, both Medtronic and academic proponents say.
Medtronic's INFUSE bone morphogenetic protein is the only product in the musculoskeletal industry that has changed the bar in terms of bone healing, and it is under fire for complications related to off-label use. As regulators and payors crack down on INFUSE and hospitals restrict access to the product, surgeons are seeking alternatives and there are a number of companies lining up to fill the void
The Yale physician behind Medtronic’s recent decision to hand over all of its raw data on the embattled Infuse spinal bone graft for independent analyses and ultimate release to the broader research community sees the development as not only a smart decision for Medtronic but also as a major step forward in creating a model for the device and drug industries.