The Senate committee launched its investigation after the Spine Journal published a letter penned by a group of spine surgeons who alleged the Medtronic-funded studies did not fully explain the serious adverse outcomes associated with Infuse. The researchers connected with the Medtronic-funded reports rejected the notion that their research was inaccurate.
Following the journal’s letter, the Senate finance committee reviewed Medtronic documents, which showed the device maker had paid $210 million to researchers conducting research on Infuse from 1996 to 2010. The committee also concluded Medtronic added language to make it seem Infuse was superior to competing products.
In response, Medtronic denied any involvement in editing or enhancing language in studies of its Infuse product and argued royalty payments to researchers aligned with industry practices.
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