St. Jude Medical ($STJ) is investigating the dangers of its now-recalled Riata leads, and the company says larger-diameter models are more likely to suffer from erosion.
In Phase I results, St. Jude reported that 24% of large-diameter Riata 8F leads experienced inside-out erosion, compared with 9.3% of the smaller Riata ST 7F models. The company has enrolled 775 patients around the world in the study, planning to examine the long-term performance of the recalled techs over the next two years.
St. Jude isn't changing its recommendations to physicians and patients in light of the results, and the company said the rates of erosion are consistent with past studies. "Our goal is to provide physicians timely and relevant clinical data to best support their patient management decisions," Chief Medical Officer Mark Carlson said in a statement.
Riata leads remain in about 79,000 patients since their 2011 Class I recall, and St. Jude is still working to get out from under the bad publicity generated by the failures of Riata and possible defects with its Durata line of leads. This year, the company unsuccessfully tried to get a retraction from HeartRhythm, which published a study claiming that Riata had led to more deaths than Medtronic ($MDT) Quattro leads, and the company's stock dropped 6% after concerns over Durata came to light.
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