St. Jude bags CE mark for MRI-compatible pacemaker

Quadra Allure MP cardiac resynchronization therapy pacemaker--Courtesy of St. Jude Medical(STJ)

St. Jude Medical picked up a CE mark allowing patients implanted with its cardiac resynchronization therapy pacemaker to undergo magnetic resonance imaging. The approval opens up more diagnostic imaging options for heart failure patients with the implant.

St. Jude’s Quadra Allure MP cardiac resynchronization therapy pacemaker (CRT-P) is now the only device of its kind with MultiPoint pacing tech and MRI conditional labeling, according to a statement. MultiPoint pacing has the potential to improve patient response to cardiac resynchronization therapy, as compared to traditional single-site pacing. It delivers pulses to multiple sites on the left ventricle rather than just one pulse for each heartbeat, according to the statement. The device works with a lead that has four electrodes that can be placed in a variety of configurations to tailor pacing to each patient.

An estimated 23 million people worldwide live with congestive heart failure, with about 2 million new cases diagnosed each year. The CE mark would enable patients in Europe to undergo imaging in a 1.5-tesla machine. MRI is used to diagnose a number of conditions, including stroke and Alzheimer’s disease. Previously, patients with the Quadra Allure pacemaker could not receive imaging due to a possible interaction between the device and the MRI.

“This new technology allows patients who have heart failure that is challenging to manage to receive more effective therapy and still be able to get an MRI for other medical conditions if needed,” said Dr. Philip Adamson, a vice president and medical director of global research at St. Jude Medical, in the statement.

In the MRI-compatible cardiac device space, Medtronic earned an FDA green light for its line of cardiac rhythm and heart failure devices last month. The approval allows patients with devices such as conditional pacemakers, implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators and leads to receive MR imaging in 1.5-tesla and 3-tesla machines.