St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union to add magnetic resonance imaging conditional labeling to its Quadra Allure MP cardiac resynchonization therapy pacemaker.
The company’s Quadra Allure MP CRT-P is now cleared as operable with diagnostic MRI scans of up to 1.5 Tesla, the St. Paul, Minn.-based company said.
“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,” St. Jude global R&D medical director Dr. Philip Adamson said in a press release.
The Quadra Allure MP comes with the company’s MultiPoint tech, which allows physicians to tailor pacing therapy by controlling multiple pulses to the left ventricle for each heartbeat. Each lead in the system can deliver 2 pulses per heartbeat, St. Jude said.
“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,” Georg Nölker of Bochum, Germany’s Ruhr-University said in a prepared statement.
The company said its Quadra Allure MP CRT-P is compatible with SyncAV CRT software to automatically adjust pacing based on changes in the users cardiac condition.
In March, St. Jude said it won CE Mark approval in the European Union for 3 new Quartet left ventricular leads.
The newly released leads are designed for more effective targeting of individual cardiac anatomies for patients who require cardiac resynchronization therapy pacers and defibs, the company said.
St. Jude Medical said the leads are designed to be used with next-gen MultiPoint Pacing technologies which allows for pacing in multiple locations on the left side of the heart.
