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St. Jude To Seek Retraction Of Riata Defibrillator Lead Study | cialis online

St. Jude To Seek Retraction Of Riata Defibrillator Lead Study

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Medical device maker, St. Jude Medical, Inc., is seeking a retraction on a Riata defibrillator lead study. The manuscript, accepted for publication in the journal Heart Rhythm, is entitled, “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads.”

St. Jude Medical says the report presented results from a review of the reported deaths linked to the St. Jude Medical Riata® and Riata ST defibrillation leads versus the Medtronic Quattro Secure leads. Data was based on a search of the U.S. Food and Drug Administration (FDA) Manufacturers and User Facility Device Experience (MAUDE) database. The review, written by Dr. Robert Hauser, et al., drew conclusions about how Riata and Riata ST leads compare with Medtronic’s Quattro Secure leads.

A defibrillator lead, is a thin wire attached to the heart wall that delivers an electrical impulse to the heart via an implantable defibrillator. Late last year, St. Jude recalled both its Riata and Riata ST defibrillator leads after it was found that the wires could potentially penetrate their insulation, which would compromise the device’s integrity; exposed wires could lead an internal defibrillator to inappropriately shock some patients or fail to deliver life-saving therapy,. At the time of the recall, St. Jude said two deaths were linked to exposed Riata wires.

Dr. Hausers invovled deaths caused by a separate issue: the wearing away of the wire’s silicone insulation, which can lead to dangerous high-voltage events. According to St. Jude, Dr. Hauser’s research minimized the number of deaths in the MAUDE database for Quattro Secure, leading to errors in how the Riata and Riata ST were compared to Quattro’s Secure lead. St. Jude Medical’s independent search of the MAUDE database found 377, not 62, reports of deaths involving Quattro Secure leads, which is what Dr. Hauser’s report indicates. St. Jude accuses Dr. Hauser’s manuscript of being mistaken or misleading in an array of areas, including that it only includes one Quattro Secure lead model and the Riata and Riata ST models.

St. Jude Medical said it was not consulted prior to the publication, nor asked to validate the data against its returns analyses and said it has spent hundreds of hours attempting to reach Dr. Hauser’s conclusions, but has been unable to do so. St. Jude feels that the analyses used duplicate reports, inconsistent categorizations, and failures to include all available reports, and that the method of study was inappropriate citing the MAUDE database, which states, “MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.”

“Given these factual errors and biased analysis, we are requesting that the manuscript immediately be retracted by the authors and removed from online publication by the official journal of the Heart Rhythm Society,” said St. Jude Medical.

But, according to the New York Times, St. Jude’s issue is the “third highly visible safety episode” in the past “seven years.” St. Jude is not the only heart device maker that’s seen problems in recent years. Since 2005, Guidant, which sold its heart unit the following year to Boston Scientific, and Medtronic, have had their heart devices linked to deaths and injuries, the result of faulty devices, said The Times.

St. Jude Medical argues it has acted appropriately in how it has advised physicians about the issue. Daniel J. Starks, St. Jude’s chief executive, told The Times in a telephone interview, “We’ve been more transparent than others.” Experts disagree, saying that St. Jude Medical took top long to issue warnings, said The Times, which noted that Riata devices are implanted in some 128,000 patients around the world.

Some heart device experts say that problems with data or devices made by St. Jude, Guidant, and Medtronic are not new and that problems with St. Jude devices came to light from external researchers, not its own monitoring systems and that St. Jude seemed to have minimized the problems. “They have, at multiple steps, underplayed the gravity of the situation,” said Dr. Kenneth Ellenbogen, a device expert in Richmond who consulted for St. Jude and its competitors, wrote The Times.

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