Riata / Durata More Bad News!!!!

Discussion in 'St Jude Medical' started by Anonymous, Sep 29, 2011 at 10:50 PM.

  1. Anonymous

    Anonymous Guest

    A friend just sent me an analyst report from Wells Fargo that exposes how bad Riata really is, and how St. Jude is vastly under estimating the failures and not providing proper recommendations (like looking for exposed conductors with fluoro) to physicians. A lot of information in it about many doctors not being confident with using 7 French leads.

    It's pathetic that a Wall Street analyst knows more about this issue than St.Jude's physicians.

    You guys are soooooooooo screwed!!!!!!!!!!!!!!!
     
  2. Anonymous

    Anonymous Guest

    Here's a little piece.. The time frame will be shorter though and Dr's will stop implanting Durata because its the same internal design

    Here comes the BOOM........

    Summary. Based on our physician checks, we expect the problems with the
    STJ Riata ICD lead to become more visible within the medical community over
    the next 6-9 months. In our view, the degree to which this impacts STJ’s ICD
    business (33% of total STJ sales) will depend on (1) the scope of the problem; (2)
    how well STJ handles the issue; (3) how STJ recommends managing active Riata
    patients; (4) the competitor response; and (5) any actual or perceived spillover to
    STJ’s newer Durata lead. At the very least, we think the increased prominence of
    this issue will make it more difficult for STJ to gain share in the ICD market,
    which is a key component of the bull case on this name. If STJ does not handle
    this issue well, it could result in the company losing share to MDT and BSX. We
    are lowering our valuation range to $36-38 from $49-50 to reflect the recent
    softness in cardiology procedures, the strengthening of the dollar vs. the Euro,
    and the Riata issues described in this note.
    • We Expect The Noise Level Around Riata To Increase. Over the next 6-
    9 months, we expect additional studies on the Riata malfunction rate to be
    presented at medical meetings such as the American College of Cardiology (ACC)
    in March 2012 and the Heart Rhythm Society (HRS) meeting in May 2012.
    Physicians with whom we have spoken expect the failure rate in the recently
    presented Irish study (15%) to be replicated based on the relatively high number
    of Riata insulation defects seen in the FDA MAUDE database. At some point, we
    would expect STJ to issue recommendations on how to screen and manage these
    patients. If STJ recommends conducting a fluoroscopy on these patients every
    3-6 months, we think a large number of patients with insulation defects will be
    identified and the nuisance of screening such a large number of patients may
    cause some backlash against STJ among implanters.
     
  3. Anonymous

    Anonymous Guest

    Stj it's D-day. You pathetic pieces told NO ONE about your issues and now it's coming from not only we competitive reps but Wall Street!!!!! Seriously???? WTF!!! You are done. Your POS company is too small to survive this storm. LMAO. No mercy.
     
  4. Anonymous

    Anonymous Guest

    You're kidding, right? To small? Shut the fuck up. Even at worst cast scenario, the failure rate will be 1/2 of Fidelis and with BSX's 20 recalls, if you work for EITHER company, you are throwing the proverbial stone from the balcony of your glass house.

    Just shut the fuck up and worry about whats going on at your company. Oh yeah, and PLEASE go out and tell your Docs about the issues so we can go in and remind them about how YOUR company fucked up their practice in the last 2 years!
     
  5. Anonymous

    Anonymous Guest

    We still had a quattro lead the doctors trusted. Good luck selling a 7 FRENCH LEAD WITH THE SAME SHITTY DESIGN!!!!!!!!

    The failure rates will be much higher that Fidelis, and you guys look like assholes when Wall Steet knows more about your problems then you do!
     
  6. Anonymous

    Anonymous Guest

    Hi. I'm an ICD rep for BSX/MDT (take your pick) and my volumes are down 10% this year, along with the rest of the market, so I"m spending all of my time on Cafepharma taking shots at STJ. Isn't this productive? I wonder why we keep laying people off?
     
  7. Anonymous

    Anonymous Guest

    You're missing the point. It's not about the # of Fidelis vs. Riata/Durata....it's about how STJ is handling it. There is an industry expectation after all the previous recalls that companies have learned how to report their failures. There is no tolerance amongst physicians and they can care less about the #'s and it's about the lack of ethics being exercised by STJ. STJ is too small to go 2 yrs without a defib lead and it will put you out of business if this goes to recalll status.. FYI -JEFFERIES just posted another analyst review on the RIATA Lead....wheels are coming off the sh** wagon boys!
     
  8. Anonymous

    Anonymous Guest

    Spoken like a rep from a SMALL failing company. ICD sales are 33% of your companies sales. That's scary. When Durata is pulled from the market what will you do? Your failure to report until 1000 failures and failure to deliver this info to your customers
    Is going to do you in. you can't survive losing 33% of sales. This wouldn't have happened had you just been honest. You probably didn't tell your docs did you?
     
  9. Anonymous

    Anonymous Guest

    I can't stop smiling!!!
     
  10. Anonymous

    Anonymous Guest

    anyone have the note from Jeffries?
     
  11. Anonymous

    Anonymous Guest

    We sell Brady leads to Boston basically under the same premise, no reason we can't ramp up Linox production too.
     
  12. Anonymous

    Anonymous Guest

    St. Jude Medical (STJ)
    How Do You Solve a Problem Like Riata?
    Key Takeaway
    Concern is growing over STJ's Riata Lead. The 7F ICD lead is no longer implanted
    and the failure rate suggested by the company is quite low, but some clinicians
    that are seeing increasing failures with the lead and are again questioning the
    safety of smaller leads, with some reports of centers not implanting down-sized
    leads at all. This is of particular issue for St. Jude, as they do not offer a larger
    lead in their current portfolio.
    Focus on Riata appears to be increasing on the heels of clinical papers and
    physician awareness of potential issues. The recent abstract presented at European
    Society of Cardiology in late August has gained traction, with some clinicians and investors
    concerned about the potential for increasing failure rates with the St. Jude Riata lead model.
    The issue is being worsened by the company denying any problem exists — all the way from
    tech support to the investor relations department — which is creating a level of frustration
    from those seeking additional information or guidance on how to address this issue. There
    are reports that some centers have stopped implanting smaller sized leads, which essentially
    blocks out St. Jude as they offer only 7F sized leads in their current portfolio.
    On December 10, 2010, St. Jude issued a Dear Doctor letter to physicians indicating
    the discontinuation of the silicone Riata lead and noted the worldwide failure rate due
    to insulation breaches is 0.47% taking into consideration 227,000 silicone Riata leads
    implanted. While the published failure rate remains quite small, some clinicians are now
    indicating they believe the failure rate could be trending higher as the leads age and
    physicians start to proactively inspect the leads via fluoroscopy, which should detect any
    potential insulation breaches.
    To be clear, the issues seen with the Riata lead to date appear to be more cosmetic, with lead
    insulation breaches, rather than catastrophic failure of the lead. However the lack of clarity
    on how to manage this issue is creating concern among the clinical community.
    Valuation/Risks
    We use 12x our 2012 EPS to arrive at a one-year price of $44 (from $55). The 12x multiple is in
    line with current levels and reflects the uncertainty growing in the company's ICD franchise.
    Other risks include slower CRM share gains, slowing in overseas growth, and regulatory risk
     
  13. Anonymous

    Anonymous Guest

    Durata anyone????? Look this up on MAUDE......a picture paints what a thousand words can not.

    St. Jude Durata 7120 (24.5 months of implant)


    EdgeofOptimSplitTearofOptimSiliconeRupture
     
  14. Anonymous

    Anonymous Guest

    Do you have a link?
     
  15. Anonymous

    Anonymous Guest

    Just google Jefferies Riata report on 9/30/2011
     
  16. Anonymous

    Anonymous Guest

    Insulation Defects of Thin High-Voltage ICD Leads: An Underestimated Problem?
    September 20, 2011 0 Comments
    Insulation Defects of Thin High-Voltage ICD Leads. Background: Long-term lead failure is a known complication of ICD therapy. The precise incidence and sequelae of insulation defects at the tricuspid level, however, are not well characterized.
    Objective: This study determined the risk of lead failure, with particular emphasis on insulation defects at the level of the tricuspid valve, in a large series of consecutive ICD recipients.
    Methods: Data from 357 consecutive patients, who had received transvenous 7 and 8 French ICD-leads (St. Jude Medical, Riata family) and were followed at our center, formed the basis of this study.
    Results: During a mean follow-up of 42 ± 24 months, 30 of 357 (8%) patients required surgical intervention due to lead failure. For overall lead defects, lead access via the subclavian vein and subpectoral device placement were independent predictors of overall lead failure (OR 3.47, 95% CI 1.38–8.72, P = 0.013 and OR 3.83, 95% CI 1.77–8.27, P = 0.001, respectively). Lead insulation defects at the level of the tricuspid valve accounted for 20% of all lead failures. Diagnosis of this specific insulation defect could only be established by fluoroscopy, while electrical parameters were within normal limits in all of these patients. On univariate but not on multivariate analysis the presence of nonischemic cardiomyopathy was a predictor of this lead complication (OR 8.2, CI 1.5–46.1, P = 0.02).
    Conclusion: Insulation defects of 7 and 8 French ICD leads at the tricuspid level represent an important complication of device therapy. Even moderate changes in lead impedance within the normal limits at follow-up should prompt careful fluoroscopic evaluation to avoid spurious shocks.
    (J Cardiovasc Electrophysiol, Vol. 22, pp. 1018-1022, September 2011)
    DAMIR ERKAPIC M.D.1, GABOR Z. DURAY M.D.1, TAMAS BAUERNFEIND M.D.1, SALVATORE DE ROSA M.D.2, STEFAN H. HOHNLOSER M.D., F.H.R.S.1
    Article first published online: 1 APR 2011
    DOI: 10.1111/j.1540-8167.2011.02055.x
     
  17. Anonymous

    Anonymous Guest

    Lets just say all of upper mgmt on the West coast was well aware of problems with Durata and later Riata....from the Bay area to Sacramento, etc....it is real, whether SJM sweeps it under the rug for their stock price...here's the deal does this company give a damn about patients???? I say not...but it's all about the stock price!!
     
  18. Anonymous

    Anonymous Guest

    Do any of you care about those of us who have these devices? Or just about your income?
     
  19. Anonymous

    Anonymous Guest

    I care. My thoughts to you as a patient is, I'm sorry you had to find out like this. I do regret that you are reading these horrific posts and think this could pertain to your risk of death. The truth is, if you have this lead, you are already deemed a high risk for sudden cardiac death or deadly arrhythmia (the whole reason you have the defib). If you are concerned, I mean really concerned, ask your doctor to look at it. Be adiment. It's your body, your life. You have the right to be proactive and take control of your situation. If he / she refuses, seek help elsewhere.

    I wish you the best.

    not a STJ employee
     
  20. Anonymous

    Anonymous Guest

    I am a patient too. And I LOVE reading the posts here. They are an honest and sobering window into the hearts and minds of CRDM industry. Your callousness and disregard for your own cohorts never ceases to amaze me.

    Now in words you can understand: You are a bunch of pathetic trolls.
     

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