St. Jude’s Durata defibrillator ‘immune’ to Riata flaws?

St. Jude's Durata defibrillator immune to Riata flaws?

St. Jude Medical (NYSE:STJ) pulled its Riata implantable cardiac defibrillator leads in 2010 after mounting evidence suggested that the Riata leads were prone to abrading through their insulation. The move cast a pall over over St. Jude’s newer ICD lead offerings, the Riata ST Optim and Durata leads.

A year later 2 Riata models were officially recalled, contributing to the concerns about the Riata ST Optim and, especially, the Durata leads. St. Jude sought to allay the concerns by pointing out that the silicon insulation on the newer leads is thicker and more durable than their predecessors’.

This month 1 of the cardiologists who helped call attention to the problems with the Riata leads, Dr. Ernest Lau, said the Durata and ST Optim leads are probably "immune" to the problems that led to the Riata recall.

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In fact, the Durata lead "doesn’t have the capacity to develop externalization," Lau told Bloomberg earlier this month, based on his bench model of the physical stresses exerted on the leads after implantation. Although his benchtop model is "crude," Lau wrote in the June 7 edition of the online journal inPACE, it suggests that the ST Optim and Durata products "should be relatively immune" to the earlier Riata problems.

"Fundamentally, the Durata and Riata leads are very different," Lau told Bloomberg. "It’s unlikely that Durata will have internal shorting as a frequent problem.

"I’ve been using the Durata lead quite a lot and I haven’t seen any internal shorting at all. With the Riata lead, it was quite common," he added.

Lau’s conclusions echo independent findings touted by St. Paul, Minn.-based St. Jude during the Heart Rhythm Society’s annual meeting in May. That study demonstrated 99.4% freedom from all-cause mechanical failure at 5 years following implantation for the Durata leads. In March, the U.S. Justice Dept. shuttered its probe into the Riata affair, according to a regulatory filing.

The medical device company is bullish about the prospects for Durata, with STJ executive Rachel Ellingson telling analysts earlier this month that St. Jude is "feeling really good" about Durata.



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