today biotronik icd leads recall .....

Discussion in 'Biotronik' started by anonymous, Jun 22, 2016 at 8:21 AM.

Tags: Add Tags
  1. anonymous

    anonymous Guest

    been in my territory for 8 years - averaged 150 devices a year - 60/40 Brady / tachy - never had a Brady lead go bad and have had 2 tachy leads go bad and 1 was fried with electrocaudery at changeout; the other broke...

    all you douchebags are full of shit and would never be on a biotronik board unless you are losing business in a flat market to smaller company who are making real commissions while you work for peanuts for 2 different managers and cranking out useless reports and business plans, scrounging for dinner programs, and realize if you ever left no one would care and no one would switch their business because of you... Very simple...
     

  2. anonymous

    anonymous Guest

    many of us doucbags have seen your POS falling apart and most of us have seen the large studies showing how you have the worst lead in the industry. I am and guessing a lot of others are sick of losing some business based mostly on the unethical BS you guys do. I agree you have grown and pay well but the studies showing high failure rates are not being published by jealous reps.

    Don't identify yourself, because when the truth comes out about Linox, you will be begging for someone to save you.
     
  3. anonymous

    anonymous Guest

    any other company would have recalled that lead by now. No wonder they never had a lead recall.
     
  4. anonymous

    anonymous Guest

    So very very true! They have never had a lead recall because they have hidden all the many lead failures from view. Its amazing how they quote "growth" as if its proof that BINC leads are great. Fact: After many, many gen changes going from BINC POS to actual quality products, my EP's, all of them, will never implant a BINC POS ever again.
     
  5. anonymous

    anonymous Guest

    Jealous much? Still waiting for the recall clowns. Can't wait for Abbott to clean house. Maybe SJM will get out from under those pesky government inquiries listed on your last 10Q.
     
  6. anonymous

    anonymous Guest

    Maybe you won't have a recall on Linox. It will be the first time in history there are multiple publications showing a much higher failure rate than other leads that hasn't happened without out a recall. Maybe we are all jealous, be we are not the ones publishing this data
     
  7. anonymous

    anonymous Guest

    This person makes a good point. Abbott will want to get any bad press out asap. Look for advisories and recalls.
     
  8. anonymous

    anonymous Guest

    what was listed?
     
  9. anonymous

    anonymous Guest

    Long-Term Evaluation of Biotronik Linox Family of ICD Leads
    Introduction
    Expert consensus holds that post-market, systematic surveillance of ICD leads is essential to ensure confirmation of adequate lead performance. GALAXY (NCT00836589) and CELESTIAL (NCT00810264) are ongoing multicenter, prospective, non-randomized registries conducted to confirm the long-term safety and reliability of Biotronik leads.

    Methods and Results
    ICD and CRT-D patients are followed for Linox and Linoxsmart ICD lead performance and safety for 5 years post-implant. All procedural and system-related adverse events (AEs) were assessed at each follow-up, along with lead electrical parameters. An independent CEC of EPs adjudicated AEs to determine AE category and lead relatedness. The analysis used categories of lead observations per ISO 5841-2 (Third edition).

    A total of 3,933 leads were implanted in 3,840 patients (73.0% male, mean age 67.0 ± 12.2 years) at 146 US centers. The estimated cumulative survival probability was 96.3% at 5 years after implant for Linox leads and 96.6% at 4 years after implant for Linoxsmart leads. A comparison of the Linox and Linoxsmart survival functions did not find evidence of a difference (P = 0.2155). The most common AEs were oversensing (23, 0.58%), conductor fracture (14, 0.36%), failure to capture (13, 0.33%), lead dislodgement (12, 0.31%), insulation breach (10, 0.25%), and abnormal pacing impedance (8, 0.20%).

    Conclusions
    Linox and Linoxsmart ICD leads are safe, reliable and infrequently associated with lead-related AEs. Additionally, estimated cumulative survival probability is clinically acceptable and well within industry standards. Ongoing data collection will confirm the longer-term safety and performance of the Linox family of ICD leads.
     
  10. anonymous

    anonymous Guest

    1. Long-Term Evaluation of Biotronik Linox Family of ICD Leads
      Introduction
      Expert consensus holds that post-market, systematic surveillance of ICD leads is essential to ensure confirmation of adequate lead performance. GALAXY (NCT00836589) and CELESTIAL (NCT00810264) are ongoing multicenter, prospective, non-randomized registries conducted to confirm the long-term safety and reliability of Biotronik leads.

      Methods and Results
      ICD and CRT-D patients are followed for Linox and Linoxsmart ICD lead performance and safety for 5 years post-implant. All procedural and system-related adverse events (AEs) were assessed at each follow-up, along with lead electrical parameters. An independent CEC of EPs adjudicated AEs to determine AE category and lead relatedness. The analysis used categories of lead observations per ISO 5841-2 (Third edition).

      A total of 3,933 leads were implanted in 3,840 patients (73.0% male, mean age 67.0 ± 12.2 years) at 146 US centers. The estimated cumulative survival probability was 96.3% at 5 years after implant for Linox leads and 96.6% at 4 years after implant for Linoxsmart leads. A comparison of the Linox and Linoxsmart survival functions did not find evidence of a difference (P = 0.2155). The most common AEs were oversensing (23, 0.58%), conductor fracture (14, 0.36%), failure to capture (13, 0.33%), lead dislodgement (12, 0.31%), insulation breach (10, 0.25%), and abnormal pacing impedance (8, 0.20%).

      Conclusions
      Linox and Linoxsmart ICD leads are safe, reliable and infrequently associated with lead-related AEs. Additionally, estimated cumulative survival probability is clinically acceptable and well within industry standards. Ongoing data collection will confirm the longer-term safety and performance of the Linox family of ICD leads.

      Quote
    Reply to Thread
    Page 2 of 2
     
  11. anonymous

    anonymous Guest

    Heart Rhythm. 2016 May;13(5):1075-82. doi: 10.1016/j.hrthm.2015.12.038. Epub 2015 Dec 29.
    Failure rate and conductor externalization in the Biotronik Linox/Sorin Vigila implantable cardioverter-defibrillator lead.
    Noti F1, Lam A1, Klossner N1, Seiler J1, Servatius H1, Medeiros-Domingo A1, Nam Tran V1, Haeberlin A1, Fuhrer J1, Tanner H1, Roten L2.
    Author information

    Abstract
    BACKGROUND:
    We observed a case of conductor externalization in a Biotronik Linox lead.

    OBJECTIVE:
    The purpose of this study was to investigate lead performance of the Linox lead and the identical Sorin Vigila lead and prevalence of conductor externalization.

    METHODS:
    We compared lead performance of all Linox and Vigila leads implanted at our center (BL group; n = 93) with that of all Boston Scientific Endotak Reliance leads (ER group; n = 190) and Medtronic Sprint Quattro leads (SQ group; n = 202) implanted during the same period. We screened all patients in the BL group for conductor externalization.

    RESULTS:
    We identified 8 cases of lead failures in the BL group (index case of conductor externalization, 6 cases of nonphysiological high-rate sensing, and 1 case of high-voltage conductor fracture). Prospective fluoroscopic screening of 98% of all active BL group cases revealed 1 additional case of conductor externalization. The median follow-up was 41, 27, and 29 months for the BL group, ER group, and SQ group, respectively; lead survival was 94.9%, 99.2%, and 100% at 3 years and 88%, 97.5%, and 100% at 5 years (P = .038 for BL group vs ER group and P = .007 for BL group vs SQ group using the log-rank test). Younger age at implant was an independent predictor of lead failure in the BL group (adjusted hazard ratio 0.85; 95% confidence interval 0.77-0.94; P = .001).

    CONCLUSION:
    At our center, survival of the Linox lead is 88% at 5 years and significantly worse than that of other leads. Conductor externalization is present in a minority of failed Linox leads. Younger age at implant is an independent predictor of Linox lead failure.

    Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

    KEYWORDS:
    Conductor externalization; Defibrillator lead; Endotak Reliance; Lead failure; Linox; Sprint Quattro
     
  12. anonymous

    anonymous Guest

    J Cardiovasc Electrophysiol. 2015 Mar;26(3):274-81. doi: 10.1111/jce.12583. Epub 2014 Dec 22.
    Early failure of the Biotronik Linox implantable cardioverter defibrillator lead.
    Padfield GJ1, Steinberg C, Karim SS, Tung S, Bennett MT, Le Maitre JP, Bashir J.
    Author information

    Abstract
    INTRODUCTION:
    The Linox and Durata implantable cardioverter defibrillator (ICD) leads were introduced to British Columbia (BC) in 2008. We determined their performance and the potential risk factors for lead failure in a large population-based patient registry.

    METHODS AND RESULTS:
    We used the BC Cardiac Registry, a mandatory Governmental database of ICD implants, to identify all recipients of Linox and Durata leads in BC between October 2008 and April 2012, and those subsequently undergoing reoperation. Lead failure was defined as recurrent nonphysiological high-rate sensing unrelated to external electromagnetic interference or T-wave oversensing; a sudden rise in impedance unrelated to perforation or lead dislodgement; or abnormal lead parameters with definite evidence of lead fracture or insulation failure. We determined the estimated cumulative lead survival by the Kaplan-Meier method, and the risk factors for lead failure in a proportional hazards model. Over a median of 39 (27-50) months, the Linox failed more frequently than the Durata (16/477 [3.4%] vs. 4/838 [0.4%]; P < 0.001), and had a significantly lower estimated cumulative survival (91.6 [80.6-96.5]% vs. 99.4 [98.4-99.8]% at 5 years; P < 0.0001). Linox failure was characterized by high-rate nonphysiological sensing (11 cases), and/or a sudden impedance rise (7 cases). Insulation failure was clearly confirmed in 6 cases of Linox failure. Female sex was a significant risk factor for Linox failure (adjusted HR = 2.1[1.3-3.4]; P = 0.004).

    CONCLUSIONS:
    This multicenter registry indicates a high rate of Linox lead failure, particularly in female patients. Ongoing surveillance of the Linox ICD lead performance is recommended.

    © 2014 Wiley Periodicals, Inc.

    KEYWORDS:
    Durata lead; Linox lead; failure rate; implantable cardioverter-defibrillator; lead failure
     
  13. anonymous

    anonymous Guest

    screwed :)
     
  14. anonymous

    anonymous Guest

    I guess these physicians must just be jealous they don't work for Biotronik and thats why they published that Biotronik ICD leads are much less reliable than leads from other CRM companies.
     
  15. anonymous

    anonymous Guest

    their own shitty data says they are twice as bad at 5 years as everyone else for christ sake!
     
  16. anonymous

    anonymous Guest

    None of us would ever had a ICD lead recall either if we were ok with such bad reliability!
     
  17. anonymous

    anonymous Guest

    twice as bad as not bad at all in any way possible is not bad at all.... what a god damn douche
     
  18. anonymous

    anonymous Guest

     
  19. anonymous

    anonymous Guest

    Go back to your safe place Troll.
     
  20. anonymous

    anonymous Guest

    Work in a center that has over 200 active leads. Seeing almost no issues.