Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

Mediacal device maker St. Jude Medical, Inc. (STJ: Quote) 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.

Register
To receive FREE breaking news email alerts for St. Jude Medical Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Swiss drug maker Roche Holding said a late-stage trial of its breast cancer drug Kadcyla did not provide superior results compared with an existing therapy. FCA US, until recently known as Chrysler, said Friday it is recalling 257,000 Dodge Ram pickups. The auto maker says the rear axle pinion nut on certain model year 2005 Dodge Ram 1500 trucks may loosen due to an undersized spline on the pinion gear. If the pinion nut loosens, the rear axle may... This medical device company has a very impressive track record of growing business over the past decade. increasing sales from $490.2 million in 2004 to $1.72 billion this year. The Silicone Hydrogel daily disposable lens portfolio constitutes a major avenue for growth.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.