Beyond INFUSE: Spine Community Searches For Answers, Alternatives
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
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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.
In less than a month, the US Food and Drug Administration (FDA) recently approved three spine PMAs, two for cervical disc replacement devices, and there are two more cervical discs in the queue for near-term PMA approval. All of this activity suggests the $122 million US cervical disc market is about to gear up.
Although the spine market appears to be stabilizing to some extent, the vertebral compression fracture market continues to be challenged by reimbursement issues and lingering controversy stemming from the New England Journal of Medicine articles questioning the efficacy of vertebroplasty and vertebral augmentation as a treatment for VCFs.