Quadra Allure MP CRT-P gets CE mark approval for MRI labeling



St Jude Medical has announced CE mark approval for magnetic resonance (MR) conditional labeling for the company’s Quadra Allure MP cardiac resynchronisation therapy pacemaker (CRT-P).

The Quadra Allure MP CRT-P, with MultiPoint pacing technology, offers patients the flexibility to undergo full-body diagnostic magnetic resonance imaging (MRI) scans of up to 1.5 Tesla for other conditions.

“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 is needed,” says Georg Nölker (Heart and Diabetes Center NRW at Ruhr-University of Bochum, Germany).

The Quadra Allure MP CRT-P with MRI labeling is designed to work with the Quartet LV, which has four electrodes to offer maximum flexibility for different pacing configurations to help manage heart failure patients.

“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 do not 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,” says Philip B Adamson, vice president and medical director of global research and development at St Jude Medical.

Multiple clinical trials, including a recent study, demonstrate that MultiPoint pacing technology may be particularly beneficial in patients not responding to traditional biventricular pacing therapy, which accounts for approximately one third of the total population of patients receiving CRT.

The new Quadra Allure MP CRT-P with MRI labeling is also compatible with the SyncAV CRT software, which automatically adjusts pacing based on real-time changes in a patient’s cardiac condition, also provides physicians the opportunity to further improve treatment of patients who have responded positively to traditional CRT.

While the Quadra Allure MP CRT-P with MultiPoint Pacing and SyncAV CRT technology is approved in the USA, the company announced it continues to work toward approval for MR-conditional labeling.