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St. Jude says its wires have low problem rate
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St. Jude Medical Inc. said Thursday that data from four studies tracking performance of "Riata"-brand heart-defibrillator wires in thousands of patients show very low rates of serious problems, including fractures and perforations.
Problems with defibrillator leads, or wires that connect the devices to hearts, became a big issue late last year when Medtronic Inc. recalled certain thin-diameter leads because of fracturing problems. Questions later arose about the performance of St. Jude leads amid reports from some centers of rare but serious perforations -- the lead poking holes in a patient's heart.
St. Jude, based in Little Canada, responded with data indicating its Riata leads had a very low rate of perforations. The data released Thursday, and presented at the Heart Rhythm Society's annual conference in San Francisco, further the case, St. Jude said.
"This builds on what we released" and also "validates" that earlier information, said Mark Carlson, chief medical officer and senior vice president of clinical affairs for St. Jude's cardiac rhythm management division.
St. Jude's biggest business includes heart-rhythm devices such as pacemakers and implantable cardioverter defibrillators, or ICDs, which treat people at risk for sudden cardiac death. The company competes with Medtronic and Boston Scientific Corp.
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