St. Jude Medical received FDA approval for its Allure Quadra cardiac resynchronization therapy pacemaker (CRT-P), as well as for the Assurity and Endurity pacemakers. The Allure Quadra is the first pacemaker approved in the U.S. that provides quadripolar pacing capabilities via the four electrodes on the leads that extend to the heart. Traditional pacemakers are bipolar, limiting the options that the cardiologist has in terms of signal pathways through the myocardium. Because it can be adjusted more effectively after implantation, quadripolar technology can help prevent unnecessary lead repositioning procedures.
The Assurity and Endurity are more tradtiional pacemakers, available in single or dual chamber varieties. All of the newly available devices interface with St. Jude Medical’s Merlin.net online reporting system that keeps transmits device data to the patient’s physician for review.
From the announcement:
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.
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.
Press release: St. Jude Medical Announces FDA Approvals of New Pacemakers