Medtronic “Repurposes” Spine Convention Booth To Tell Its Side of BMP Story
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.
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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.
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.
The March 26 special fraud alert reiterates the HHS watchdog’s “longstanding position that the opportunity for a referring physician to earn a profit, including through an investment in an entity for which he or she generates business, could constitute illegal remuneration under the anti-kickback statute.”