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St. Jude Medical Inc. Message Board

  • randomwisenheimer randomwisenheimer Jan 26, 2012 8:34 PM Flag

    Riata Lead Summit - Presentations Posted

    The presentations made at the Riata Lead Summit have been posted.

    The most interesting presentations were The Independent Multicenter Study: Preliminary Results and Lead Survival: VA National Cardiac Device Surveillance Experience.

    The multicenter study was conducted at the Mayo Clinic, Minneapolis Heart Institute, Summa Cardiovascular Institute, University of Pittsburgh Medical Center, University of Virginia, Vanderbilt University Medical Center, and Beth Israel Deaconess Medical Center. Here are the highlights from their conclusions. "The survival of Riata (but not Riata ST) leads was significantly lower than [Medtronic's] Quattro Secure Leads; however the Riata ST have shorter follow-up than the Riata leads." "Our data suggests that externalized conductors are common in dual coil Riata leads; nearly a third were malfunctioning." "Oversensing was a frequent sign of lead failure and a half of these resulted in inappropriate therapy. Impedance and threshold changes were also common".

    Analysis of data collected from the VA found "significant differences in the survival probability of Riata versus other high voltage leads, as well as survival differences in Riata 7000 versus 1500 series." As you can clearly see in the survival curves on page 4 of the "Lead Survival: VA National Cardiac Device Surveillance Experience" presentation, Riata's survival rate is significantly inferior to that of Boston Scientific's Endotak Reliance lead and Medtronic's Quattro. Riata as a whole isn't as bad as Medtronic's disastrous Fidelis lead but the Riata 7000 series by itself seems to have comparably failure rates at 5 years.

    As you may have heard in St. Jude's QA period during the conference call, Stark said "most of the physicians who attended that meeting were people that really are very close to one of our competitors and don't do much business with us. And a number of them in my understanding is really -- don't, never did implant Riata in the first place." He goes on to describe it as a "non-event". I think the multicenter nature of studies as well as the actual Riata implant data presented makes those comments seem disingenuous at best. The doctors presenting at this conference are a who's-who's of cardiology and Starks dismissive attitude towards serious accusations of product defects that are backed up by data is disturbing.

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