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

This article was originally published in The Gray Sheet

Executive Summary

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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Medtronic Infuse Adverse-Event Reporting Gaps Spotlighted

The Minneapolis-based Star Tribune says Medtronic failed to report more than 750 adverse events uncovered during a 2006-2008 chart review of Infuse patients. But the company struck back, saying the newspaper’s version omits key facts.

J&J’s Clinical Data Disclosure Strategy Focuses On Collaboration With Yale University Group

In what appears to be the most expansive policy to date on release of clinical trial data, J&J will use an existing outside group and will share full clinical study reports and patient-level data regardless of when the studies were conducted.

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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