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Senators Seek Info On Medtronic Infuse | cialis online

Senators Seek Info On Medtronic Infuse

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In the midst of probes, shareholder lawsuits, and broad criticism concerning its Infuse bone growth product, Medtronic is making headlines again. This time, three senators are asking for information on Medtronic’s Infuse product.

Senators Charles Grassley (Republican-Iowa), Herb Kohl (Democrat-Wisconsin), and Richard Blumenthal (Democrat-Connecticut) asked, in a letter described by The Star Tribune as having an “investigational tone,” for very specific information on how Medtronic monitors its products once they are released and for information on Infuse.

The six-page Medtronic letter is one of five similar letters sent to other medical device makers whose products have failed after being released to the market, said The Star Tribune. The three senators also introduced legislation to mandate device makers conduct clinical studies of their products after release to the market for all products released via the controversial fast-tracked 510(k) approval process that allows device makers to skip intense pre-market testing that involves, for instance, human trials.

The senators discussed potential conflicts of interests in the letter to Medtronic, specifically concerning Infuse. “A researcher at Stanford University School of Medicine found a higher risk of cancer associated with Infuse, and there have been allegations that researchers who received funds from Medtronic, sometimes millions of dollars, did not report negative findings from clinical trials,” the letter states, wrote The Star Tribune.

Meanwhile, NewsInferno just wrote that a shareholder lawsuit alleging that Medtronic illegally promoted Infuse off-label has been granted class action status. The lawsuit was filed by a number of institutional investors on behalf of Medtronic shareholders who purchased or acquired the stock during November 2006 – November 2008 and who suffered financial losses.

This summer, said NewsInferno, Medtronic was accused of downplaying Infuse’s more serous side effects and, recently, a renowned researcher warned that Infuse may be linked with increased cancer risks. Also, said NewsInferno, in Medtronic’s recent 10-Q filing with the U.S. Securities and Exchange Commission (SEC), Medtronic disclosed that California’s Attorney General’s Office issued a subpoena to Medtronic in October as part of its Infuse investigation. Infuse is also the focus of a U.S. Justice Department probe spearheaded by the U.S. Senate Finance Committee, said NewsInferno

Infuse bone graft is made from the genetically engineered rhBMP-2 (recombinant human Bone Morphogenetic Protein-2), a material that stimulates bone growth and which was approved by the U.S. Food and Drug Administration (FDA) in 2002 for use in one type of spine surgery: lumbar fusion, NewsInferno explained. Subsequently, Infuse was approved for use in two types of dental surgeries; however many patients have undergone spinal fusion surgeries and received Infuse bone graft implantation in which nonapproved methods were utilized or in which other spinal parts, for which Infuse was not approved, were involved. NewsInferno pointed out that in July 2008, the FDA warned that Infuse and other, similar bone growth products, were know to cause significant problems when used off-label in spinal procedures.

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