St. Jude Gets CE Mark For MRI-Safe Quadra CRT Pacemaker
By Jof Enriquez,
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St. Jude Medical says it has received CE Mark approval for magnetic resonance imaging (MRI) conditional labeling for its Quadra Allure MP cardiac resynchronization therapy pacemaker (CRT-P). The designation means patients in Europe implanted with the device can safely undergo full-body MRI scans of up to 1.5 Tesla to diagnose or monitor other conditions.
The Quadra Allure MP CRT-P device is part of St. Jude's portfolio for treating congestive heart failure, which affects 23 million people worldwide. Approximately one-third of the total population of patients receiving CRT use devices that do not respond well to traditional bi-ventricular pacing therapy, according to St. Jude. The company says the Quadra's proprietary, first-to-market MultiPoint Pacing technology is designed to better manage these patients. Heart failure patients also are likely to experience heart failure progression, or have other serious medical conditions which warrant subsequent MRI scans post-implantation of cardiac devices.
“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,” said Prof. Georg Nölker, head of the Electrophysiology, Heart and Diabetes Center NRW at Ruhr-University of Bochum, Germany, in a news release.
MultiPoint Pacing technology utilizes the compatible Quartet lead, featuring four electrodes to deliver electrical pulses to multiple left-ventricular tissue locations — rather than the traditional single pulse for each heartbeat -- to make the heart’s lower chambers pump in a more coordinated way, according to St. Jude. The company touted positive study results from a recent trial for said CRT pacing technology at the Heart Rhythm Society's (HRS) 37th annual scientific sessions in May. That backed up a 2015 study showing improved acute LV function and LV reverse remodeling at three months for patients who received MPP-activated CRT devices made by St. Jude.
St. Jude says the Quadra Allure MP CRT-P device also is compatible with the company's SyncAV CRT technology, which automatically adjusts pacing based on real-time changes in a patient’s cardiac condition.
“The Quadra Allure MP is the only CRT-P with MultiPoint Pacing technology, MRI full-body labeling, and more clinical options to treat patients who don’t respond to initial pacing therapy. 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 B. Adamson, VP and medical director of global research and development at St. Jude Medical.
According to the company – which is on the verge of being acquired by Abbott – it is working toward attaining U.S. Food and Drug Administration (FDA) approval for MR-conditional labeling for the CRT device.