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St. Jude Medical’s new pacemakers receives FDA approval

The US Food and Drug Administration (FDA) has approved St. Jude Medical’s Allure Quadra cardiac resynchronization therapy pacemaker (CRT-P) and the Assurity and Endurity pacemakers.

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St. Jude Medical obtained CE Mark approval in March 2013 for its Allure Quadra CRT-P and the Assurity and Endurity pacemakers. The company plans to introduce these devices in the US market by the end of the first quarter in 2014.

Allure Quadra CRT-P works by offering multiple pacing options that allow for enhanced re-synchronization of the heart beat for patients suffering from heart failure. It brings the quadripolar lead technology to the pacemaker market for the first time.

The additional options help manage common pacing complications without exposing the patient to additional surgeries for lead repositioning. The Allure family of devices also offers enhanced heart failure diagnostics, including CorVue impedance monitoring, for improved patient management.

Device information from the Allure Quadra CRT-P is automatically transmitted to the secure St. Jude Medical website, Merlin.net Patient Care Network, as well as to the patient’s electronic health record, where the information can be viewed by medical professionals.

The Assurity and Endurity pacemakers have been designed for longevity. They feature a 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), the Assurity and Endurity pacemakers provide a higher level of care at implant and through patient’s lives.

The Assurity pacemaker, using RF technology, automatically transmits device data to a physician or care team without any action by the patient. The Endurity pacemaker, using inductive telemetry, rapidly provides device data during interrogation.

The two pacemakers are supported by the Merlin.net Patient Care Network website for remote patient management.

St. Jude Medical group president Dr Eric S. Fain noted that the company is the leader in quadripolar pacing technology, provided in its 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.

"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," Dr Fain added.

Over 100 clinical publications have provided broad clinical evidence until now in support of the advantages of St. Jude Medical’s quadripolar technology.


Image: St. Jude Medical’s Allure Quadra Cardiac Resynchronization Therapy Pacemaker. Photo: Courtesy of Business Wire,St.Jude Medical Inc.