ST. PAUL, Minn., Jul 16, 2012 (BUSINESS WIRE) -- St. Jude Medical, Inc., a global medical device company, today announced initial findings from the Riata(R) Lead Evaluation Study. The study's phase-one results found that externalized 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, a dedicated resource for providing the latest information on Riata leads.
The Riata Lead Evaluation Study is an international, multicenter, prospective study of Riata and Riata ST silicone defibrillation leads. It enrolled 724 patients at 20 sites in the U.S. and Canada. An additional 51 patients were enrolled at three sites in Japan. Those results are awaiting final adjudication and will be reported at a later date.
The study will continue to evaluate the performance of Riata leads - both with and without externalized conductors - over the next two years to determine how they function over time, which may help further inform patient management considerations. In other clinical studies, the majority of leads with an externalized 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."
An experienced physician panel adjudicated fluoroscopic images using objective criteria for the presence or absence of externalized conductors in enrolled patients' leads. The St. Jude Medical independent Leads Medical Advisory Board has reviewed the results and recommends no changes to existing patient management recommendations.
Based on an analysis of products returned to St. Jude Medical, externalized conductors in Riata leads are most frequently associated with inside-out abrasion, which occurs when the cables housed within the outer insulation of the lead work their way outside of the lead body as the result of movement against the insulation. External, or outside-in, abrasion is a known cause of failure across all cardiac leads in the industry, and is different from the inside-out abrasion seen with externalized conductors in some Riata leads.
Externalized conductors can be visualized through x-ray or fluoroscopy; however, it is important to note that externalized conductors may be visualized without any associated clinical or device-related observations. In the majority of reported cases, a lead with an externalized conductor continued to function normally.
For additional background information on Riata leads, including a pre-recorded webinar discussing these results and other patient management considerations, please visit riatacommunication.com.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2012. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
SOURCE: St. Jude Medical, Inc.