St. Jude Medical Announces FDA Approvals of New Pacemakers

First pacemaker with quadripolar technology now available in the U.S.

 

March 26, 2014

St. Jude Medical Inc. has received 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 (HF). The company also announced FDA approvals for the Assurity pacemaker and Endurity pacemaker families of devices.

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 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 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 hospitalizations.

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 pacemakers received clearance in March 2014.

For more information: www.sjm.com