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St. Jude Seeks Retraction Of Heart Rhythm Journal Manuscript By Dr. Hauser

Mediacal device maker St. Jude Medical, Inc. (STJ) said Friday that it is seeking a retraction of the manuscript accepted for publication in the Heart Rhythm Journal by Dr. Robert Hauser, et al., titled, "Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads." The manuscript presented results from an analysis that assessed the number of death reports associated with St. Jude Medical Riata and Riata ST defibrillation leads compared with rival Medtronic, Inc.'s (MDT) Quattro Secure leads.

In the analysis, the authors classified the deaths in one of three categories, lead related, indeterminate or not lead related, and drew conclusions about how Riata and Riata ST leads compare with Medtronic's Quattro Secure leads.

The assessment was based on a search of the U.S. Food and Drug Administration Manufacturers and User Facility Device Experience, or MAUDE, database.

St. Jude said using the same search criteria outlined in the manuscript, it has identified that Dr. Hauser's research 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.

St. Jude said its independent search of the MAUDE database found 377 reports of deaths involving Quattro Secure leads, not 62 as stated by Dr. Hauser in a manuscript posted online and accepted for publication in the Heart Rhythm Journal.

Dr. Hauser's manuscript is mistaken or misleading in a number of other respects as well, the company noted.

St. Jude said it was not consulted prior to the publication, nor asked to validate any of the data against its returns analyses.

The method of the study itself, using MAUDE reports to compare devices, is not appropriate, the company alleged.

by RTT Staff Writer

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