St. Jude Medical presents new data on quadripolar technology at Heart Rhythm 2014

St. Jude Medical, Inc.May 9 2014

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, is the leader in quadripolar technology with the only cardiac resynchronization therapy (CRT) system approved in the U.S. New data presented at Heart Rhythm 2014, the Heart Rhythm Society's Annual Scientific Sessions, demonstrates increased survival, 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 multi-point pacing (investigational device in the U.S.), makes St. Jude Medical's quadripolar system the standard-of-care in improving the management of CRT.

For the first time, St. Jude Medical quadripolar leads were compared head-to-head with bipolar leads in a retrospective, observational study. Data from the study were presented at a featured poster session titled Reduced Mortality with Quadripolar versus Bipolar Left Ventricular Leads in Cardiac Resynchronization Therapy, by Dr. Mintu Turakhia. With more than 23,000 patients, one of the largest populations reviewed to date, this study of newly-implanted CRT-Ds with the St. Jude Medical quadripolar left ventricular (LV) pacing system was associated with increased patient survival compared to patients implanted with bipolar LV pacing systems.

"This comparative effectiveness study is an important advancement in our understanding of the real world impact of St. Jude Medical's quadripolar technology," said Dr. Mintu Turakhia, assistant professor of Medicine at Stanford University. "These data are the most compelling thus far as they demonstrate that the St. Jude Medical quadripolar lead is associated with a statistically significant improvement in survival."

The study evaluated survival outcomes for CRT patients using the Quartet^™ quadripolar LV lead, which offers alternative pacing vectors not available with bipolar LV leads. Comparing survival rates for patients with a quadripolar vs. bipolar lead, the study compared patients with newly implanted cardiac resynchronization therapy defibrillator (CRT-D) systems receiving the two different types of CRT leads. Among the more than 23,000 patients identified through St. Jude Medical's device registration records as receiving a new CRT-D system, the number of deaths per 100 patient years in patients with a quadripolar lead (5.84 deaths) is statistically significantly lower than that of the patients with a bipolar lead (7.14 deaths) with a highly significant p-value of 0.004. This demonstrated an 18.2 percent reduction in mortality with quadripolar leads compared to bipolar leads suggesting that patients with the quadripolar LV leads may receive more effective CRT therapy.

"St. Jude Medical has an unwavering commitment to investing in disruptive technologies that transform the treatment of expensive epidemic diseases such as heart failure. We developed and launched the first quadripolar system in 2009 to manage the dynamic challenges of heart failure," said Eric S. Fain, M.D., group president of St. Jude Medical. "With more than five years of commercial experience, the St. Jude Medical quadripolar system is redefining the standard-of-care in resynchronization therapy for heart failure patients around the world, now including the important clinical outcomes measure of all-cause survival."

The industry-leading quadripolar pacing system offers physicians the ability to effectively and efficiently manage the ever-changing needs of patients with heart failure. The system integrates multiple pacing configurations and Tailored Therapy^™ features that enable physicians to optimize the system at implant and follow-up, as well as better manage common pacing complications without having to surgically reposition the lead. The system is also approved for remote patient management, utilizing the Merlin.net^™ Patient Care Network. The recent Food and Drug Administration (FDA) approval of the Allure Quadra CRT-P brings quadripolar lead technology to the U.S. pacemaker market for the first time.

The Quartet lead design allows the physician to implant the lead in the most stable position without making trade-offs in electrical performance. This includes pacing closer to the base of the left ventricle, which studies associate with better patient outcomes and which may be more difficult with traditional bipolar leads. The quadripolar pacing electrodes also provide physicians more options to optimize CRT performance, such as pacing around scar tissue in the heart and avoiding the most common pacing complications.

Sessions throughout HRS 2014 showcase the body of clinical evidence for quadripolar pacing:

• Reduced Costs Post CRT with Quadripolar LV leads compared to Bipolar LV leads
  Featured Poster - May 7 at 6 p.m. PT in the Exhibit Hall

• Multipoint Left Ventricular Pacing in Cardiac Resynchronization Therapy Patients Provides Similar Acute Hemodynamic Improvement Regardless of QRS Duration or Lead Location
  Poster - May 8 at 9:30 a.m. PT in the Exhibit Hall
  • The Quadra Assura MP™ CRT-D is being evaluated under a U.S. FDA IDE.
• RV Paced to LV Sensed Conduction Times Measured on Quadripolar LV leads: Prolonged Conduction to the Proximal Electrodes
  Poster - May 8 at 3:30 p.m. PT in the Exhibit Hall

• The Incidence of Vector Viability with the New St. Jude Medical Quadripolar Lead During Biventricular Pacing
  Poster - May 8 at 3:30 p.m. PT in the Exhibit Hall
• Vector Co-Viability Supports Suitability of Quadripolar Coronary Sinus Lead for the Purposes of Multisite LV Pacing in Patients Undergoing Cardiac Resynchronization Therapy
  Poster - May 8 at 3:30 p.m. PT in the Exhibit Hall
  • The Quadra Assura MP CRT-D is being evaluated under a U.S. FDA IDE.
• Hospitalization Rates and Associated Cost Analysis of Quadripolar versus Bipolar CRT-D: a comparative analysis of a single-center prospective Italian registry
  Presentation - May 9 at 1:45 p.m. PT in room 2010, Moscone West

• The FOURWARD Study: Variations in Left Ventricular Electrical Delay with LV Quadripolar Leads and Implications for CRT Therapy
  Poster - May 9 at 3:30 p.m. PT in the Exhibit Hall

• Incidence of Phrenic Nerve Stimulation in a Large Series Comparing Conventional Vectors Available on Bipolar Leads Versus Quadripolar Exclusive Vectors Using St Jude 1458Q
  Poster - May 9 at 3:30 p.m. PT in the Exhibit Hall