Medtronic Giving Yale Grant to Review Bone Growth Data (written by Barry Meier @ NY Times Health)
Facing intensifying scrutiny over one of its bone growth products, Medtronic announced Wednesday that it was giving a $2.5 million grant to Yale to oversee a complete review of the study data that examined the product’s safety and effectiveness.
In June, a medical journal charged that researchers sponsored by Medtronic had generated misleading studies about the product, called Infuse, that overstated its benefits and asserted that it did not pose risks.
Infuse is a bioengineered material used primarily in spinal fusions, a procedure in which vertebrae are joined to reduce back pain. Industry analysts have speculated that sales of Infuse have dropped since the periodical, The Spine Journal, published its special issue on the product.
Experts said that Medtronic’s action was the first time that a medical device maker would turn over the underlying and detailed patient data from company-sponsored studies to independent experts so that they could review it and draw their own conclusions.
Typically, companies release only summaries of that information, a practice that can hamstri...
