St. Jude defends Durata amid FDA warning at manufacturing facility

January 10, 2013 by Arezu Sarvestani

St. Jude Medical CEO Daniel Starks says the FDA's warnings of manufacturing deficiencies at a California plant are unrelated to the safety and reliability of the Durata defibrillator leads that are made there.

St. Jude Medical CEO Daniel Starks

St. Jude Medical's (NYSE:STJ) implanted cardiac device market share is in great shape despite ongoing issues with its high-voltage defibrillator leads, CEO Daniel Starks told an audience at the J.P. Morgan healthcare conference last night.

Starks spent a substantial portion his presentation and the subsequent breakout session explaining why the Durata line was a sure thing, and why the Riata lead recall and FDA warnings related to a St. Jude manufacturing plant were no threat to the company's hold on the larger ICD market.

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The medical device company also released its preliminary results for fiscal 2012, beating analysts' expectations on an expected $1.37 billion in sales for the 4th quarter, including a 2% slide in ICD revenue. Starks was tight-lipped about any solid projections for 2013, as the company plans to release its formal earnings guidance later this month.

St. Jude has devoted a lot of time in recent months to recovering from the high-profile recall of its Riata line of defibrillator leads and the negative halo effect on the company's next-generation Durata line, which has come under increased scrutiny from the FDA as well as from some analysts.