St. Jude Medical, Inc., has gone public with initial findings from its Riata Lead Evaluation Study. The study’s phase-one results found that externalised conductors occurred in 9.3 percent of the smaller-diameter Riata ST 7F leads in the study, and in 24 percent of the larger-diameter Riata 8F leads.
A full summary of the phase-one study results are available on the company’s riatacommunication.com website, the company’s dedicated resource for providing the latest information on Riata leads.
The Riata Lead Evaluation Study is an international, multicentre, prospective study of Riata and Riata ST silicone defibrillation leads. 724 patients were enrolled at 20 sites in the U.S. and Canada. An additional 51 patients were enrolled at three sites in Japan, results for which are not yet available.
Aside from the clear concern raised by the proportion of leads that have failed, the study’s greatest value comes from the continued evaluation of Riata leads – both with and without externalised conductors – over the next two years to determine how they function over time. The commentary from all sides in the discussions thus far have been most concerned about the management of patients with Riata leads, which this study may help to further inform.
St.Jude is keen to point out that in other clinical studies, the majority of leads with an externalised conductor continued to function normally.
“The rates of externalized conductors in this study are consistent with other published studies involving fluoroscopic screening of patients with Riata leads. This study also reinforces that externalized conductors are more prevalent in larger-diameter Riata leads,” said Dr. Mark Carlson, chief medical officer and senior vice president of clinical affairs for the St. Jude Medical Cardiac Rhythm Management Division. “We are now focused on collecting longer-term data in the second phase of this study. Our goal is to provide physicians timely and relevant clinical data to best support their patient management decisions.”
Source: St.Jude Medical, Inc., PR Newswire