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FDA approvals of new pacemakers

Manufacturing Group | March 26, 2014

First pacemaker with quadripolar technology from St. Jude Medical Inc. is now available in the United States

St. Jude Medical Inc., a global medical device company, 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.

Source: St. Jude Medical

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