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 that showed that the U.S. Food and Drug Administration is concerned about the quality systems in place to design and validate Durata and the Riata ST Optim products at a plant in California.
Matt Taylor, an analyst with Barclays, asked 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. And so those data are robust data. They are third-party audited data and those data reflect a 98.7 percent survival of the Durata lead line at five years compared to competitive [products’] 98.1 percent five-year survival. All along here, with respect to Durata, the facts have been very friendly to us. … We do expect to see various centers publish their experience with the Durata leads … and we expect those data to be favorable. So I think there isn’t a single event. There just is an ongoing confidence and ongoing reinforcement of positive safety and reliability performance of the Durata lead line that will increasingly become front of mind for people as they think about their lead choices.
While the five-year data may be promising, St. Jude Medical’s recent history with recalled leads does not inspire complete confidence. The Riata 8F lead was recalled in late 2011, more than 10 years after it was introduced in mid-2001, while the Riata ST 7F lead was introduced in mid-2005 and recalled also in late 2011. St. Jude stopped selling these leads in 2010.