No Advantage For Medtronic’s InFuse Versus Bone Graft In Spine Fusion

Article preview from Medtech Insight - July 2013

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.

No Advantage For Medtronic’s InFuse Versus Bone Graft In Spine Fusion

Article preview from Medtech Insight - July 2013

The initial published clinical reports on Medtronic Inc.’s InFuse as a substitute for bone grafts in spinal fusion surgery understated the risks of the recombinant human bone morphogenetic protein-2 (rhBMP-2) relative to its benefits, according to two independent reviews of the clinical evidence published last week in the Annals of Internal Medicine.

The conclusions of the two analyses were mixed on the proper role, if any, of InFuse in spinal surgery cases going forward. Analysts suggest the data could have a nominal impact on the market for the already poorly performing product, or could drive sales down further.

Medtronic and academic proponents of the company’s effort to release raw data on InFuse tout the recent publications as a watershed moment for open-access industry data. Critics of InFuse in the spine surgery community say that Medtronic’s development and marketing of the product in the last decade is a cautionary tale.

“On the basis of the currently available evidence, it is difficult to identify clear indications for rhBMP-2 in spinal fusion,” Rongwei Fu, PhD, of Oregon Health & Science University in Portland, and colleagues conclude based on their analysis of patient-level data from 17 Medtronic-sponsored studies of rhBMP-2 in spinal fusion. Fu and colleagues write that they “found substantial evidence of reporting bias and no evidence that rhBMP-2 is more effective than iliac crest bone graft in spinal fusion, with some evidence of an association with important harms.” Moreover, “early journal publications misrepresented the effectiveness and harms through selective reporting, duplicate publication and underreporting.”

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