St Jude Medical announced that it 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.
“We recognise that the phenomenon of externalised conductors may present a complex patient management scenario for physicians and we have initiated a prospective study to better understand this failure mechanism,” said 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.”
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 externalised. In patients with externalised conductors, electrical performance of the leads will be assessed every three months for two years. First enrolment in the study occurred in December 2011.