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Medtronic Funds Yale Reviews of Infuse BY SANDER DUNCAN, AUGUST 5, 2011

Following significant media and academic backlash against Infuse, Medtronic is taking several novel steps toward developing data transparency and defending the science behind its product. Medtronic announced a $2.5 million grant to Yale earmarked for two independent, third-party studies of Infuse, its leading BMP-2 product. To assist Yale with its studies, as well as others investigating the matter, Medtronic will make all of its Infuse data, both published and unpublished, available to researchers. Further, Medtronic will publish to ClinicalTrials.gov all of its clinical-trial results on Infuse to date, including those trials completed before 2007 when the requirement to do so was enacted. Yale's Dr. Harlan Krumholz, who will be directing the studies, called this action a "landmark model for data transparency."

The Yale grant is the latest development in a rough summer for Medtronic and its $800 million per year bone-growth product. In May, a retrospective review of Medtronic's Infuse study showed a correlation between male patients treated with Infuse and sterility. The controversy continued in June when the Spine Journal dedicated an entire issue to the subject, highlighting the under-reporting of adverse events and risks associated with Infuse. Omar Ishrak, Medtronic's new CEO, is spearheading the defense of Infuse and has said, "Integrity and patient safety are my highest priorities."

Yale expects to complete its reviews within six months and to publish its data within 18 months.

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