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St. Jude's Riata large-diameter leads have most problems: study
July 16, 2012 / 2:53 PM / 5 years ago

St. Jude's Riata large-diameter leads have most problems: study

CHICAGO (Reuters) - St. Jude Medical Inc said on Monday initial findings from a study on its Riata defibrillator leads, which were recalled in late 2011, showed that lead erosion that occurred from the inside out happened most frequently in larger diameter leads.

Phase one results indicated inside-out erosion occurred in 9.3 percent of the smaller diameter Riata ST 7F leads in the study, compared with 24 percent of the larger diameter Riata 8F leads.

The international study of Riata and Riata ST silicone defibrillation leads enrolled 724 patients at 20 sites in the United States and Canada. An additional 51 patients were enrolled at three sites in Japan. Results are being finalized and will be reported at a later date.

The St. Paul, Minnesota-based heart device maker, the second largest manufacturer of implantable heart defibrillators, said the study will continue to evaluate the performance of the leads over the next two years.

“We are now focused on collecting longer-term data in the second phase of this study,” Dr. Mark Carlson, chief medical officer and senior vice president of clinical affairs for the St. Jude Medical Cardiac Rhythm Management Division, said in a prepared statement.

St. Jude voluntarily stopped selling the leads in December 2010. In December 2011, the U.S. Food and Drug Administration classified the product as a Class I recall.

Reporting by Debra Sherman; editing by Jeffrey Benkoe

Our Standards:The Thomson Reuters Trust Principles.
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