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St. Jude Medical (STJ) Announces FDA Approvals Of New Pacemakers



3/24/2014 6:43:29 AM

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St. Jude Medical Announces FDA Approvals of New Pacemakers

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced approval from the U.S. Food and Drug Administration (FDA) for the Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P), which provides additional pacing innovations for physicians to treat patients with heart failure. The company also announced FDA approvals for the Assurity™ pacemaker and Endurity™ pacemaker families of devices.

“St. Jude Medical is the leader in quadripolar pacing technology, provided in our high voltage CRT-D devices since 2009. In International markets where the Allure Quadra CRT pacemaker is available, we experience strong demand and significant share capture as the technology has become the standard of care for many physicians,” said Eric S. Fain, M.D., group president at St. Jude Medical. “Through product offerings like the Allure Quadra CRT-P and the Assurity and Endurity pacemakers, we continue to deliver innovation through a full continuum of pacemaker options.”

Allure Quadra CRT-P

The Allure Quadra CRT-P system brings quadripolar lead technology to the U.S. pacemaker market for the first time. Quadripolar technology facilitates additional pacing configurations within the heart that offer physicians options not available in traditional bipolar systems. These additional options help physicians to manage common pacing complications without exposing the patient to additional surgeries for lead repositioning. To date, more than 100 clinical publications have provided broad clinical evidence in support of the advantages of quadripolar technology from St. Jude Medical.

The Allure family of devices also offers enhanced heart failure (HF) diagnostics that can help with patient monitoring and offer insights into disease progression and management. Device information from the Allure Quadra CRT-P is automatically transmitted to the secure St. Jude Medical website, Merlin.net™ Patient Care Network (PCN) as well as to the patient’s electronic health record, where the information can be viewed by medical professionals.

“Adding the clinical benefits of quadripolar technology to pacemakers will expand the benefits of this therapy to patients. These features and additional pacing options will allow me to provide better care to patients diagnosed with heart failure and reduce the need for repeat procedures, especially for those patients who have been historically hard to treat due to tissue damage in their heart.,” said Dr. Raffaele Corbisiero, chair of electrophysiology and pacing and director of the Electromechanical Therapy Institute at the Deborah Heart and Lung Center in Browns Mills, N.J. “This could have economic benefits as well due to fewer readmissions for heart failure-related events.”

Assurity and Endurity Pacemakers

The Assurity and Endurity pacemakers are designed for longevity and feature a smaller, physician-inspired shape, early notification of atrial fibrillation-related events and pacing that helps reduce HF-related hospitalizations1. Available as a single or dual chamber pacemaker (pacing either one or both chambers of the heart), both pacemakers provide a higher level of care at implant and through patient’s lives. The Assurity pacemaker uses RF technology to automatically transmit device data to a physician or care team without any action by the patient. The Endurity pacemaker uses inductive telemetry to rapidly provide device data during interrogation. Both pacemakers are supported by the Merlin.net™ Patient Care Network (PCN) website for remote patient management.

The Allure Quadra CRT-P and the Assurity and Endurity pacemakers received CE Mark in March 2013. St. Jude Medical intends to launch these products in the U.S. by the end of the first quarter in 2014.

About Heart Failure

More than 5 million Americans have heart failure (HF) with 670,000 new cases diagnosed each year. Roughly 1.4 million patients in the U.S. have NYHA Class III HF, and historically these patients account for nearly half of all HF hospitalizations. According to the American Heart Association, the estimated direct and indirect cost of HF in the U.S. for 2012 was $31 billion and that number is expected to more than double by 2030.

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

1. Faulknier B, Richards, M. (2012, Dec. 4-7). The Association of the Use of the Ventricular Intrinsic Preference (VIP™) Feature with Heart Failure Hospitalization in Pacemaker Patients. Paper presented at the XV International Symposium on Progress in Clinical Pacing, Rome, Italy.

Contacts

St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
jweigelt@sjm.com
or
Sarah Shamla, 651-756-6293
Media Relations
sshamla@sjm.com

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