Clinical Studies Memphis

Medtronic Inc. Draws Barrage Of Criticism

The criticism – which could take a toll on the company’s brand and bottom line, one analyst said – has local implications, as the Minneapolis-based company’s Spinal and Biologics Business is in Memphis at Learn more about 1800 Pyramid Place

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Jan Wald, a medical device analyst with Morgan Keegan & Co. Inc ., said trials are conducted independently and data is presented independently.

The study published in Spine Journal claims researchers working with Medtronic failed to report complications related to Infuse Bone Graft, a widely used spinal surgery product in more than a dozen research papers.

“That had a lot more to do with the kinds of trials that were being conducted, and a lot of those trials were investigator-initiated trials,” Wald said. “Medtronic doesn’t have much ability to influence the way the trial is conducted or in the way that the data is presented.”

Wald also said there should have been more editorial oversight on the part of Spine Journal, saying, “I think there’s blame there, as well.”

He emphasized, however, that Medtronic isn’t entirely off the hook.

Infuse Bone Graft, a recombinant human Bone Morphogenetic Protein-2 whose purpose is to stimulate bone formation, first received U.S. Food and Drug Administration approval in 2002.

“If you were to go back to Medtronic’s filings for Infuse with the FDA, you would’ve seen these complications,” Wald said. “I don’t think it’s fair to say the company didn’t disclose; they didn’t do anything about it. They didn’t write a letter to the journal saying ‘Wait a minute; these guys didn’t disclose that there could be complications.’ They let it hang.”

In a June 28, statement, Medtronic’s chairman and CEO Omar Ishrak acknowledged that the Spine Journal articles raise questions about the researchers’ conclusions in published peer reviews, but said the articles don’t raise questions about the data submitted to the FDA during the approval process or the information available to doctors using the product.

“For several years, Medtronic has been leading the industry in reforms designed to eliminate or mitigate conflicts of interest,” Ishrak said. “We will continue to investigate questions surrounding researchers’ potential conflicts of interest, refine our policies as warranted, and strive to lead the industry in ethical and transparent business practices.

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A few of these research studies are mentioned below:

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