“We recognize that the phenomenon of externalized conductors may present a complex patient management scenario for physicians and we have initiated a prospective study to better understand this failure mechanism”
St. Jude Medical, Inc. has launched a Riata Lead Communication website at RiataCommunication.com. The new website is dedicated to providing physicians a compilation of important communications and updated information regarding the recent Riata® and Riata® ST Silicone Defibrillation Leads Class I recall.
Certain of St Jude medical’s Riata and Riata ST Models were the subject of a voluntary recall by the company in 2011 following reports of a high incidence of device “externalisation”. One single center site in Belfast, Northern Ireland, had indicated a 15% incidence rate of externalized conductors in Riata silicone leads (25 out of 165 patients) during fluoroscopic screening, including 5 leads (3%) that were associated with an electrical abnormality. One significant finding out of the Belfast experience is that a large percentage (35%) of the patients with Riata leads at the site had Riata (8Fr) single shock coil models. Analysis of worldwide complaint and returns information has identified that Riata (8Fr) single shock coil models exhibit a significantly higher incidence rate of externalized conductors than all other Riata (8Fr) and Riata ST (7Fr) models, which helps explain why the Belfast experience has shown such a high incidence rate.”
In collaboration with an independent Medical Advisory Board, St. Jude Medical has initiated a prospective clinical study to help guide any future recommendations from the company regarding patient management. A minimum of 500 patients with Riata or Riata ST silicone insulation leads of varying implant duration will undergo proactive fluoroscopy to determine if a conductor is externalized. In patients with externalized conductors, electrical performance of the leads will be assessed every three months for two years. First enrollment in the study occurred this month.
Website to keep medical and patient community informed
St. Jude Medical says it is committed to keeping customers informed about product performance. The Riata Lead Communication website will launch with the current public information available from the company and as additional information is gathered, through the Riata Lead Evaluation Study or other sources, St. Jude Medical will update the physician community and will add to the body of knowledge available on the Riata Lead Communication website.
“We recognize that the phenomenon of externalized conductors may present a complex patient management scenario for physicians and we have initiated a prospective study to better understand this failure mechanism,” said Dr. Mark Carlson, chief medical officer and senior vice president of research and clinical affairs for the St. Jude Medical Cardiac Rhythm Management Division.
“As part of our ongoing commitment to regularly update the medical and patient community on the performance of our products, we are providing this Riata Lead Communication website to help communicate all available information, including information from this study, other studies and any relevant additional information, in a timely and consolidated manner.”
Source: St Jude Medical