Patients with its Quadra Allure device will be able to undergo 1.5T MRI scans.
St. Jude Medicalhas landed the CE Mark for MRI compatibility for its Quadra Allure MP cardiac resynchronization therapy pacemaker. The European approval will allow patients who have the pacemaker to undergo full-body MRI scans of up to 1.5 T.
St. Jude’s announcement comes just weeks after FDA approved Medtronic’s full suite of cardiac rhythm and heart failure devices for compatibility with 1.5 and 3T full-body MRI scans. While 1.5T scanners still comprise the majority of MRI installations, 3T scanners may comprise more than half of new units—with some centers having only 3T scanners—since they offer faster scans and higher resolution images.
The Quadra Allure with MRI labeling is designed to work with St. Jude’s Quartet LV lead, which has four electrodes for different pacing configurations to help manage heart-failure patients. The technology allows physicians to capture more left ventricular tissue quickly by delivering pacing pulses to multiple left ventricle locations rather than the traditional single pulse for each heartbeat, according to a company statement.
“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,” Philip Adamson, M.D., medical director of global research and development at St. Jude, said in the statement.
“As a clinician, I want to offer my patients an advanced cardiac pacing technology that also reserves the option for them to safely undergo a full-body MRI at some point in the future if it’s needed,” added Prof. Georg Nölker, head of the Electrophysiology, Heart, and Diabetes Center NRW at Ruhr-University of Bochum, Germany.
St. Jude pointed multiple clinical trials and to a 2015 study that demonstrated that its multiple-point pacing technology may be particularly beneficial in the approximately one third of the total population of CRT patients who do not respond to traditional bi-ventricular pacing therapy.
The Quadra Allure MP CRT-P with MRI labeling is also compatible with St. Jude’s SyncAV CRT software, which automatically adjusts pacing based on real-time changes in a patient’s cardiac condition. FDA has approved the Quadra Allure and the SyncAV CRT, and the company said it is working toward FDA approval of MR-conditional labeling for the devices.