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TMCNet:  St. Jude Medical Shows Commitment to Cardiac Advancements With Comprehensive Clinical Evidence Program During Heart Rhythm 2014

[May 05, 2014]

St. Jude Medical Shows Commitment to Cardiac Advancements With Comprehensive Clinical Evidence Program During Heart Rhythm 2014

ST. PAUL, Minn. --(Business Wire)--

St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, is participating in Heart Rhythm 2014, the Heart Rhythm Society's Annual Scientific Sessions. Clinical evidence about the company's cardiac rhythm management and ablation technologies will be provided in 38 sessions, including three late-breaking clinical trial sessions. The company's latest technologies will be on display May 7-10 in booth 1002 at the Moscone Convention Center in San Francisco.

"St. Jude Medical's long-standing commitment to answering some of the medical community's most challenging clinical questions about heart rhythm disorders and heart failure is reflected in a notable podium presence at the 2014 HRS Scientific Sessions," said Dr. Mark D. Carlson, chief medical officer for St. Jude Medical. "We will continue investing in important research and developing technologies that reduce costs and improve patient outcomes."

Key sessions in which new data regarding St. Jude Medical technologies will be presented include:

Late-Breaking Clinical Trial Sessions

Heart failure and abnormal heart rhythms are expensive epidemic diseases, and St. Jude Medical is relentless in its quest to find novel treatments that benefit patients. Three important technologies from the company will be highlighted in this year's Late Breaking Clinical Trial Sessions:

  • Increased Adherence to Remote Monitoring is Associated with Reduced Mortality in Both Pacemaker and Defibrillator Patients: New findings on the Merlin™ Remote Monitoring System will be presented on May 8 at 2:30 p.m. PT in Room 305, Moscone South
  • Dual-targeted Thoracic Spinal Cord Stimulation for Heart Failure as a Restorative Treatment (SCS (News - Alert) HEART): First-in man Experience: Early findings will be presented on May 8 at 2:45 p.m. PT in Room 305, Moscone South. Products being evaluated are exclusively for clinical investigations and not being used in accordance with their approved indications for use.
  • Chronic Performance of Leadless Cardiac Pacing: One Year Follow-up to the LEADLESS Trial: Chronic data about the Nanostim™ leadless pacemaker from the CE Mark study will be presented on May 9 at 8 a.m. PT in Room 305, Moscone South. The Nanostim leadless pacemaker is being evaluated under a U.S. Food and Drug Administration (FDA) Investigational Device Exception (IDE).

Quadripolar Pacing Technologies

St. Jude Medical is the leader in quadripolar pacing technology, provided in our high voltage cardiac resynchronization therapy defibrillator (CRT-D) devices sice 2009 and now available with next-generation MultiPoint Pacing (MPP)* technology and in a CRT pacemaker (CRT-P). To date, more than 100 clinical publications have provided broad evidence in support of the advantages of quadripolar technology from St. Jude Medical. New research on the company's Quadripolar technology will be presented in the following sessions:


  • Reduced Mortality with Quadripolar Versus Bipolar Left Ventricular Leads in Cardiac Resynchronization Therapy: Poster from Dr. Mintu Turakhia et al will be on display during the Featured Poster Session on May 7 at 6 p.m. in the Exhibit Hall
  • Reduced Costs Post CRT with Quadripolar LV leads compared to Bipolar LV leads: Poster from Dr. Raffaele Corbisiero et al will be on display during the Featured Poster Session on 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 from Dr. Carlo Pappone et al will be on display on 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.
  • Hospitalization Rates and Associated Cost Analysis of Quadripolar versus Bipolar CRT-D: a comparative analysis of a single-center prospective Italian registry: Will be presented by Dr. Giovanni Forleo on May 9 at 1:45 p.m. PT in room 2010, Moscone West

*MPP pacing is being evaluated under a U.S. FDA IDE

Lead Performance

The Durata™ Defibrillation Lead with Optim™ is supported by more than six years of implant experience and robust post-market surveillance monitoring. Important evidence regarding Optim and Durata high-voltage lead performance will be presented in the following sessions:

  • Characterization of the Biostability of Insulation Materials in Human Biologically Stressed Cardiac Leads: Will be presented by Dr. Bruce Wilkoff on May 8 at 1:30 p.m. PT in room 2010, Moscone West
  • Electrical Survival Analysis of St. Jude Medical Durata and Riata ST Optim High-Voltage Leads from the VA National Cardiac Device Surveillance Program: Poster from Dr. Seema Pursnani et al will be on display on May 8 at 3:30 p.m. PT on in the Exhibit Hall
  • Optim ICD Lead Failures: Long-term Rates from Independent Analysis of 11,016 Leads in 3 Prospective Registries: Poster from Dr. John Cairns et al will be on display on May 9 at 3:30 p.m. PT 9 in the Exhibit Hall

Cardiac Ablation

The TactiCath™ irrigated ablation catheter* provides physicians with a real-time, objective measure of the force they apply to the heart wall during a catheter ablation procedure. Data from the TOCCASTAR trial, a U.S. FDA IDE for TactiCath, will be included in the following presentations:

  • Force Sensing Ablation Catheters: Have Our Hopes Been Realized?: New information from the TOCCASTAR trial will be presented during the AF Summit by Dr. Moussa Mansour on May 7 at 2:30 p.m. PT in Room 3001, Moscone West
  • Optimal Contact Force During Pulmonary Vein Isolation Improves Chronic Freedom from Recurrence of AF: Poster from Moussa Mansour with data will be on display on May 9 at 9:30 a.m. PT on in the Exhibit Hall
  • Steerable Sheath Promotes Improved Contact Force Parameters During Pulmonary Vein Isolation: Poster from Frank Cuoco with data will be on display on May 10 at 9:30 a.m. PT in the Exhibit Hall

* The TactiCath irrigated ablation catheter is being evaluated under a U.S. FDA IDE

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 (News - Alert) @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 (News - Alert), 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. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


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