New Outcomes and Cost Data Further Supports St. Jude Medical Leadership in Quadripolar Technology at HRS 2015

Use of SJM Quartet™ LV lead showed:

  • Reduced mortality of 24% with a high percent of bi-v pacing compared to bipolar leads
  • Reduced risk of shock by 13% compared to bipolar leads
  • Reduced post-implant HF hospitalization of 31% and 39% reduction in associated costs compared to bipolar leads
HRS 2015

ST. PAUL, Minn.--()--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the presentation of important data around its SJM™ Quadra CRT System during the Heart Rhythm Society's (HRS) 36th annual scientific sessions. Multiple presentations showcase improved clinical outcomes, increased survival and better cost utilization with the St. Jude Medical quadripolar cardiac resynchronization therapy (CRT) system. Combined with a strong product pipeline, the growing body of clinical evidence supporting the SJM Quadra CRT System now includes more than 130 publications, further substantiating the company’s unique and comprehensive portfolio of heart failure management solutions.

A data presentation titled Incremental Survival Benefit of High Percent Biventricular Pacing in Quadripolar CRT was presented by Dr. Michael R. Gold, who led the study. The analysis looked at 8,973 patients with high and low percentages of biventricular (bi-v) pacing with the SJM Quadra CRT System, including the Quartet LV Lead, compared to a standard bipolar pacing lead. High bi-v pacing was defined as resynchronization pacing rates equal to or greater than 93 percent. The mortality benefit of quadripolar leads was observed in both the high and low percentages of bi-v pacing patient groups. In patients with a high percentage of bi-v pacing, the risk of mortality was 24 percent lower in those with a Quartet LV lead than those with a conventional bipolar lead.

“These data show how our continued innovation demonstrates improved clinical and economic outcomes in cardiac resynchronization therapy,” said Dr. Mark D. Carlson, chief medical officer for St. Jude Medical. “The SJM Quadra CRT Systems are a key component of our leadership in heart failure solutions.”

Data was presented by Dr. Mintu P. Turakhia during a session titled Quadripolar LV leads are Associated with Decreased Shock Burden in CRT-D Patients. The analysis evaluated nearly 11,000 patients implanted with a CRT-D (8,640 with a quadripolar lead vs. 2,303 with a bipolar lead) found that the shock-free survival (chance of not getting an initial shock) was higher in patients implanted with the Quartet LV lead, showing a reduced risk of shocks by 13 percent compared to bipolar LV leads.

Additional data presentations for the St. Jude Medical quadripolar pacing system included Decreased Heart Failure Event Rates and associated Costs with Quadripolar versus Bipolar CRT-D systems, presented by Dr. Raffaele Corbisiero. These data showed that the Quartet LV lead exhibited a 31 percent reduction in post-implant heart failure hospitalization rates in the U.S. and a significant 39.8 percent reduction in associated costs compared to CRT-D patients with bipolar LV leads.

Quadripolar Pacing Technology from St. Jude Medical

St. Jude Medical introduced the industry’s first quadripolar CRT pacing system with the Quartet LV lead, featuring four uniquely spaced electrodes. The quadripolar CRT 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 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.

St. Jude Medical’s 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.

About St. Jude Medical’s Heart Failure Business

Approximately 26 million people worldwide suffer from heart failure. St. Jude Medical collaborates with heart failure specialists, clinicians and advocacy partners to provide innovative, cost-effective solutions for heart failure patients around the world. For more information about St. Jude Medical’s focus on heart failure, visit the St. Jude Medical Heart Failure Media Kit.

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 January 3, 2015. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Contacts

St. Jude Medical, Inc.
Investor Relations:
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations:
Kate Stoltenberg, 651-756-3388
kstoltenberg@sjm.com

Release Summary

SJM Quartet™ LV lead showed 24% reduction in mortality with high % bi-v pacing; reduced shock risk by 13%; post-implant HF hospitalization of 31% & 39% reduced associated costs compared to bipolar.

Contacts

St. Jude Medical, Inc.
Investor Relations:
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations:
Kate Stoltenberg, 651-756-3388
kstoltenberg@sjm.com