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Device Maker Wants Study Retracted

Wed, 04/11/2012 - 7:39am
Chris Kaiser

The beleaguered Riata defibrillator leads are once again in the news -- this time because their maker, St. Jude Medical, is seeking the retraction of a study involving the leads that was published online in the journl HeartRhythm.

The Riata and Riata ST leads for implantable cardioverter defibrillators (ICDs) were pulled from the market in 2011 because the insulation on the wires could wear out, externalizing the leads' conductors and potentially leading to device malfunction or death.

The study in question, conducted by Robert G. Hauser, MD, from the Minneapolis Heart Institute Foundation, and colleagues using data from a government database, found that out of 133 deaths associated with ICDs, 22 were identified as being caused by a failure of the Riata leads and five by a failure of the Quattro Secure lead (Medtronic).

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