Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

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

RELATED NEWS
Trade STJ now with 
4/6/2012 3:49 PM ET

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

Editors Pick
Starbucks Corp. said Thursday after the markets closed that its second quarter profit rose 9.4% from last year, helped by higher revenue. The company's quarterly earnings per share came in line with analysts' expectations, but its quarterly revenue fell short of analysts' forecast. The world's largest specialty coffee retailer also raised its full year earnings outlook. Software giant Microsoft Corp. said Thursday after the markets closed that its third quarter profit fell 6.6% from last year, when results were boosted by special upgrade offer revenues. However, the company's quarterly earnings per share came in above analysts' expectations as did its quarterly revenue. Apple Inc. said Wednesday after the markets closed that its second quarter profit rose 7% from last year, as sales surged and margins improved amid strong sales of its iPhones. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue. At the same time, the company gave a slightly downbeat revenue forecast for the current quarter.
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.