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Boston Scientific Corporation Message Board

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  • ma45342312 ma45342312 Feb 13, 2012 9:23 PM Flag


    My definition of widely reliable is a lead that is not on a class 1 recall by the FDA. WHich is the current recall on the Riata lead.

    Riata is the older lead and has been out for 8 years and begins failing at about 15 percent rate at the 72 month mark Study out of Ireland shows this.

    Durata the lead that they have been selling for 3 years or so is now starting to show the exact same failure mechanism "inside out abrasion" If FDA pulls the Durata lead St. Jude will have no tachy lead to sell.

    My definition of reliable: not on a class 1 recall by FDA or a lead that is almost structurally identical to a lead that is on a class 1 recall (Difference between Durata and Riata is outer Optimum coating everything else the same)

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