In response to the guest post summarizing the Riata ICD Lead Summit, St. Jude Medical sent the following statement to CardioBrief:
We recognize that the phenomenon of externalized conductors presents a complex patient management scenario for physicians who may be able to visualize an anomaly, but it is important to remember that most leads with externalized conductors continue to function properly.
In terms of the survey results, it is important to point out that the results are from a audience poll at a meeting where attendance included about 55 physicians. Even if everyone in the room voted on this topic, the sample size was extremely small for truly understanding overall market sentiment. In addition, it is clear from the initial survey that the audience at the summit was composed of physicians who were not representative of customers using our current Durata leads. In terms of the change in their perceptions from the first survey to the second survey, while we don’t have information on how many audience members actually participated in both surveys, we have heard from attendees that a significant number of meeting participants left the meeting before the second vote was taken. Depending on the number of people voting, it is hard to know if the changes in percentage actually demonstrated any significant change in perception.
In regards to our current-generation technology, the Durata lead continues to demonstrate excellent performance by any measure. We have ongoing prospective, actively monitored registries examining the performance of our Optim/Durata leads, representing 10,836 patients enrolled at 292 sites, with over 5 years and 24,000 patient-years of data. The Durata lead incorporates design changes that reduce cable tension and the risk of externalized conductors, as compared to prior generation leads, and features a more abrasion resistant insulation material – the company’s proprietary Optim insulation. During the more than five years it has been on the market, the Durata lead has continued to meet our very high expectations in terms of safety and reliability.
Additional information about both Riata and Durata leads is available in the presentation from the summit by Dr. Mark Carlson, Chief Medical Officer of the St. Jude Medical Cardiac Rhythm Management Division, which has been posted on our website www.RiataCommunication.com.
Disclosures: St. Jude Medical was not involved with organizing, nor did we sponsor or fund, the Riata Summit. We were invited to participate by the program directors, and as such, provided the Chief Medical Officer of our Cardiac Rhythm Management Division and several engineers and quality assurance experts to be on hand to answer questions and present requested information.
Amy Jo Meyer
Senior Manager, Public Relations and Communications
Corporate Relations
je suis très étonné de la non prise en compte en France de la gravité potentielle de la situation. Je suis moi-même porteur d’une de ces sondes riata f8 i582 et ne suis informé que grâce à mes relations avec la presse spécialisée Anglo-Saxonnne!. Je ne manque pas de remercier les auteurs qui m’ont permis d’en savoir un peu plus.
Je trouve le positionnement de st jude médical un peu léger face aux problèmes engendrés par ces dysfonctionnements, si vous prenez cette situation dans un contexte tout autre que ceux des statistiques, et que vous personnalisez le problème vous verriez que l’angoisse et le questionnement d’un porteur de ces sondes pris au hasard n’est pas à négliger , la médecine c’est autre chose qu’une courbe graphique , ce sont des milliers d’individus touchés dans leur vécu au quotidien , j’aimerai bien que vous fabricants de ces sondes défaillantes en preniez la juste hauteur de l’humain face à ce dilemme!!!!.