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Yale To Review Medtronic Infuse Bone Graft Studies For Public Release

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Medtronic Inc., the world’s biggest heart rhythm devices maker, said it will pay Yale University $2.5 million to assemble a steering committee, hire research organization to review studies of the bone product Infuse, and then design a database for the public to access the results.

This comes after reports in The Spine Journal criticized Medtronic for not disclosing financial ties to Infuse researchers, and not reporting the serious side effects in patients treated with the products.

Infuse is a genetically engineered protein approved by U.S. regulators in 2002 to spur new bone growth after spinal surgery. According to the Spine Journal’s review, Medtronic conducted 13 clinical trials on 780 patients.

Rick Kuntz, the company’s chief scientific officer, said in telephone interview by Bloomberg, “We were taken aback that there was a concern about the trustworthiness of the data with Infuse, especially since it passed the regulatory hurdles,” Kuntz said yesterday. “Had this information been publicly available, I don’t think the conclusions that were reached would have been reached.”

Because Medtronic didn’t release Infuse complications, surgeons didn’t know to look for cancers and male sterility as a result of the products use, so the number of cases reported to Medtronic and the FDA is not accurate, and Eugene Carragee, chief of spinal surgery at Stanford School of Medicine, and editor and chief of the Spine Journal said of the soon to be public study, “They simply are not going to have enough data on the main usage of it to give a really precise estimate of how safe or dangerous it is,” Bloomberg reported.

 

 

breakinglawsuitnews.com disclaimer: This article: Yale To Review Medtronic Infuse Bone Graft Studies For Public Release was posted on Thursday, August 4th, 2011 at 7:17 pm at breakinglawsuitnews.com and is filed under Medical Device Lawsuits.

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