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.
Assurity and Endurity PacemakersThe 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 hospitalizations 1. 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.