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St. Jude Medical (STJ) CEO: When it Comes to the Durata Lead, Facts Have Been Very Friendly to Us


1/23/2013 8:23:27 AM

On Wednesday, St. Jude Medical CEO Dan Starks fielded a couple of questions related to its Durata ICD lead on its fourth quarter earnings call, although there were none on a possible recall of the product, despite my expectations. The Durata ICD lead has been troubled by its association with a recalled, previous-generation ICD lead and most recently by a regulatory warning letter which showed that the Food and Drug Administration is concerned about the quality systems in place to design and validate Durata and other products at a plant in California. Matt Taylor, an analyst with Barclays, asked CEO Dan Starks to provide a “current temperature in the field on Durata” and how the company could regain market share. This is how Starks answered the question: The major information that is most compelling to physicians … is the five-year follow-up data, survival data for the Durata product line compared with other products available in the market.

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