FDA approves 3 pacemaker devices

The FDA approved three St. Jude Medical pacemaker devices, including its quadripolar cardiac resynchronization therapy pacemaker, St. Jude announced today.

The FDA’s approval paves the way for the commercial launch of the Allure Quadra Cardiac Resynchronization Therapy Pacemaker, the Assurity pacemaker and the Endurity pacemaker family of devices. St. Jude Medical reported that the Allure approval marks the first time the quadripolar technology has become available in the U.S.

The Allure’s quadripolar technology is designed to widen physicians’ options in patient care and facilitate additional pacing configurations while providing diagnostic monitoring capabilities. The Assurity and Endurity devices are smaller profile technologies available in dual and single chamber formats.

St. Paul, Minn.-based St. Jude Medical said it planned to launch the three devices by the end of the first quarter of this year.