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Large-scale Study Confirms Growing Body of Clinical Evidence for the St. Jude Medical Quadripolar System

St. Jude Medical Quartet quadripolar lead performed better than bipolar leads of any kind

ST. PAUL, Minn. & BARCELONA, Spain--(BUSINESS WIRE)-- St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced results from a large-scale, clinical study concluding that the St. Jude Medical Quartet™ left-ventricular (LV) quadripolar lead provides more options to effectively manage common pacing complications compared to systems with bipolar leads.

The MORE-CRT data, More Options available with a quadripolar LV lead pRovidE in clinic solutions to CRT challenges, was presented during a hot line late-breaking session at the European Society of Cardiology Congress 2014 (ESC 2014). Results showed that complications occurred less frequently and were managed more efficiently in patients who received the Quartet lead than in patients who received bipolar electrode leads.

“The risk of LV lead-related events was more than 40 percent lower in patients implanted with a Quartet CRT-D system relative to patients implanted with a bipolar CRT-D system,” said Prof. Giuseppe Boriani, M.D., Ph.D., of the Institute of Cardiology, University of Bologna, Italy, and the MORE-CRT steering committee chairman. “The overall freedom from intraoperative and post-operative LV lead-related events was significantly higher in quadripolar CRT group versus bipolar CRT group. These data are very important in deciding how we treat our patients going forward.”

More than 60 centers from 13 countries participated in this first randomized, large-scale clinical study of more than 1,000 patients comparing the St. Jude Medical Quartet lead to bipolar LV leads (one-third of bipolar leads were St. Jude Medical and two-thirds were non-St. Jude Medical). The primary endpoint of the study was freedom from intra- and post-operative LV lead-related events at six months.

The Quartet lead was associated with a statistically significant increase in freedom from combined LV lead-related events — 85.97 percent in patients implanted with a Quartet lead compared to 76.86 percent in patients implanted with a bipolar LV lead.

“The design of St. Jude Medical’s Quartet quadripolar technology is unique,” said Dr. Mark D. Carlson, chief medical officer and vice president of global clinical affairs for St. Jude Medical. “The MORE-CRT study confirms that our quadripolar system has set the standard for the quadripolar pacing industry and the study is a strong addition to the more than 100 publications showing our technology improves outcomes and quality while reducing costs.”

The quadripolar pacing technology is important because failed implant rates in heart failure (HF) patients receiving a cardiac resynchronization therapy (CRT) system are significantly higher with bipolar LV pacing leads due to anatomy (creating lead stability problems), phrenic nerve stimulation (PNS) or poor electrical measurements.

Leading Quadripolar Technology and Clinical Evidence

Additional data on the first-to-market MultiPoint pacing system presented during ESC 2014 includes 12 month results from the St. Jude Medical MultiPoint™ Pacing (MPP) clinical study. Twelve month results, consistent with the three month data, indicates a 19 percent increase in the number of patients responding to CRT compared to the standard-of-care, biventricular pacing. CRT response in the MultiPoint pacing study was quantified as a greater than 15 percent reduction in End Systolic Volume (ESV) and an increase in ejection fraction (EF) to baseline, two commonly used but rigorous criteria for determining CRT response. Quadra Assura MP™ CRT-D is an investigational device in the U.S. and is not commercially approved in the U.S.

Data presented at the 2014 Heart Rhythm Society’s Annual Scientific Sessions in May, Reduced Mortality with Quadripolar versus Bipolar Left Ventricular Leads in Cardiac Resynchronization Therapy, demonstrates an 18 percent reduction in mortality, as well as other improved clinical outcomes and better cost utilization with St. Jude Medical’s quadripolar technology. The large and growing body of clinical evidence combined with a strong product pipeline, including next-generation MultiPoint pacing (investigational device in the U.S.), makes St. Jude Medical’s quadripolar system the standard of care in improving the management of CRT.

Data looking at Hospitalization Rates and Associated Cost Analysis of Quadripolar versus Bipolar CRT-D: a comparative analysis of a single-center prospective Italian registry, also presented at HRS 2014, found that the use of quadripolar leads reduced the number of hospitalizations by 53 percent when compared to the non-quadripolar leads. This hospitalization rate reduction translated into a statistically significant 62 percent reduction in overall costs for both health care systems and patients.

For more news from ESC 2014, visit esccardio.org.

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.

Forward-Looking Statements

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 28, 2013 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 28, 2014. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
jweigelt@sjm.com
or
Kristi Warner, 651-756-2085
Media Relations
kwarner@sjm.com

Source: St. Jude Medical, Inc.