About the Yale Review of INFUSE® Bone Graft
Understanding the Yale independent review of rhBMP-2, the active protein in INFUSE® Bone Graft
In August 2011 Medtronic commissioned Yale University to conduct a first-of-its-kind independent review of data related to the safety and effectiveness of INFUSE® Bone Graft. Medtronic sought this review as part of an unprecedented effort to promote patient safety and transparency, and to respond to questions raised about data included in peer-reviewed medical journals about the product. Medtronic provided data from 17 completed clinical trials related to INFUSE® Bone Graft and rhBMP-2, as well as post-market adverse event (safety) reports that were submitted to the FDA. Yale independently assembled a panel of experts and selected Oregon Health & Sciences University (OHSU) and University of York in the United Kingdom (York) to conduct separate analyses of the data. The review has been completed and a report has been published in the June 18 issue of the Annals of Internal Medicine.
What is Medtronic’s reaction to the findings in Yale’s review?
We’re pleased to have reached this milestone in the completion of the systematic reviews. The results add to a growing body of evidence regarding INFUSE® Bone Graft as a safe and effective treatment option in FDA-approved indications for use. Medtronic reported complete adverse event information to the FDA during the IDE clinical trials, and that information appears in the product labeling for approved indications. Since it was FDA-approved in 2002, Medtronic has worked with the FDA to communicate the benefits and risks of INFUSE® Bone Graft so physicians have access to that important information in its labeling.
The systematic reviews considered multiple individual studies going back to 1996 and literature reports through 2012, each with different areas of focus, and combined these into two systematic reviews of the safety and effectiveness of rhBMP-2, including INFUSE® Bone Graft and investigational formulations. As with all therapies and surgical procedures, INFUSE® Bone Graft poses certain risks that must be evaluated carefully by patients and physicians before use. Medtronic is committed to providing physicians with information that helps inform their medical decisions and choice of therapy for patients.
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Office of Medical Affairs
The Office of Medical Affairs is a globally focused team that provides medical and scientific information on Medtronic Spinal products. Separate and independent from Sales and Marketing, Medical Affairs responds to questions from healthcare professionals that are outside the scope or training of the Sales and Marketing organizations, e.g., information regarding the on-label and off-label use of Medtronic Spinal products.
Contact the Office of Medical Affairs by email or phone at:
(800) 876-3133, ext. 6044.