St. Jude stands firm despite more Durata scrutiny

St. Jude's Durata leads are back in the spotlight after a journal article detailed a case of mechanical failure.--Courtesy of St. Jude Medical

A new report of a failing Durata lead has put St. Jude Medical's ($STJ) much-scrutinized device back in the spotlight, but the company is sticking to its guns, saying Durata's long-term safety data speaks for itself.

In a report published in the journal Pacing and Clinical Electrophysiology, a 55-year-old patient came in complaining of vibrations in his St. Jude Fortify defibrillator, connected to a Durata lead. Doctors switched the ICD and kept the lead but found that it was still unable to deliver a maximum shock. After subbing out Durata for Boston Scientific's ($BSX) Endotak Reliance G lead, the ICD was able to function properly.

The report's authors figure the problem stemmed from an insulation defect with Durata, caused by inside-out abrasion. That's particularly alarming as it's the very problem that forced St. Jude to recall the Riata leads, a costly process that marred the company's market share, and St. Jude has long said Durata's Optim polymer insulation prevents the same abrasion.

However, the issue involves just one lead among hundreds of thousands of Durata implants around the globe, and the company points to independent analysis that found its leads to be safe. Looking at 5-year data from a registry of more than 11,000 implantations, the Population Health Research Institute found St. Jude's leads to have a 99.9% rate of freedom from all-cause insulation abrasion and a 99.4% rate of freedom from all-cause mechanical failure.

Still, it remains to be seen whether those data are enough to quiet the worry over Durata. In January, the FDA hit St. Jude with a warning letter over its manufacturing practices at a Durata-making plant in California, driving down the company's share price and leading investors to file a lawsuit claiming it knowingly withheld the fact that the FDA was taking a hard look at Durata.

A few analysts have speculated that Durata could be in line for a recall of its own, but St. Jude has been steadfast in pointing to its independently verified safety data.

- read the abstract

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