Douglas Zipes, MD, professor of medicine at Indiana University School of Medicine and managing editor of Heart Rhythm, said St. Jude Medical's request to retract an article about its recalled Riata device "is not going to happen," according to a Star Tribune report.
In the study, researchers relied on the FDA's Manufacturers and User Facility Device Experience database to determine possible deaths stemming from St. Jude's Riata and Riata ST devices compared to Medtronic's Quattro Secure leads. They found failures with the St. Jude and Medtronic devices caused 22 deaths and five deaths, respectively.
St. Jude recently sought a retraction, saying it "substantially undercounted total deaths in the MAUDE database for Quattro Secure, which therefore resulted in substantial errors related to how Riata and Riata ST leads compared to the Quattro Secure lead."
In response, Dr. Zipes countered that the research article had undergone extensive peer review before publishing. Instead, Mark Carlson, MD, CMO at St. Jude, was offered a chance to write a letter to the editor in response to the research article. On behalf of the device company, a spokeswoman for St. Jude responded to Dr. Zipes saying the company "will continue to work through the proper channels with the Heart Rhythm Journal and the Heart Rhythm Society to ensure there is an appropriate presentation of validated, accurate information."
In the study, researchers relied on the FDA's Manufacturers and User Facility Device Experience database to determine possible deaths stemming from St. Jude's Riata and Riata ST devices compared to Medtronic's Quattro Secure leads. They found failures with the St. Jude and Medtronic devices caused 22 deaths and five deaths, respectively.
St. Jude recently sought a retraction, saying it "substantially undercounted total deaths in the MAUDE database for Quattro Secure, which therefore resulted in substantial errors related to how Riata and Riata ST leads compared to the Quattro Secure lead."
In response, Dr. Zipes countered that the research article had undergone extensive peer review before publishing. Instead, Mark Carlson, MD, CMO at St. Jude, was offered a chance to write a letter to the editor in response to the research article. On behalf of the device company, a spokeswoman for St. Jude responded to Dr. Zipes saying the company "will continue to work through the proper channels with the Heart Rhythm Journal and the Heart Rhythm Society to ensure there is an appropriate presentation of validated, accurate information."
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