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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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      Above is a link to the FDA maude database. Which shows a Durata lead that failed. This is St. Jude's current tachy lead. This was only a 38 month from implant failure. As time goes on failures will increase.

      Durata is the new lead that St. Jude is trying to say will not fail like Riata. Here is documentation that the new lead is also failing.

      FDA as many in the industry are watching this very closely. Few more reports like this to FDA and who knows what will happen.

      • 3 Replies to ma45342312
      • Typical BSX sales rep propaganda, just trash other companies products while refusing to talk about BSX's own products.

        Pointing to MDRs in the MAUDE isn't a valid way of implicating a company or product.

        Since you are totally clueless and a complete ignoramus when it comes to US Medical device regulation, this is the fine print behind an MDR:

        "DISCLAIMER: Section 21 CFR 803.16 states that "A report or other information submitted by a reporting entity under this part, and any release by FDA of that report or information, does not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, or the reporting entity or its employees, caused or contributed to the reportable event. "

        If you think you're so cool and manly because you can search for STJ MDRs in the MAUDE database, and pretend that BSX is bulletproof, you are out of your mind.

        And to implicate an entire company based one 1 MDR in the MAUDE database is a HUGE stretch. BSX must be really desperate if they are teaching their sales reps to point to MDRs in the MAUDE database as sales fodder, since their own market share is ICDs is evaporating faster than the Aral Sea.

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