St. Jude Medical (STJ) Granted CE Mark Approval for Quadra Allure MP CRT-P

November 7, 2016 8:04 AM EST

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St. Jude Medical, Inc. (NYSE: STJ) announced CE Mark approval for magnetic resonance (MR) conditional labeling for the company’s Quadra Allure MP™ cardiac resynchronization therapy pacemaker (CRT-P). The Quadra Allure MP CRT-P, with its first-to-market MultiPoint™ Pacing technology, now offers patients the flexibility to undergo full-body diagnostic magnetic resonance imaging (MRI) scans of up to 1.5 Tesla (measurement for the strength of a magnetic field) 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’s needed,” said Prof. Georg Nölker, Head of the Electrophysiology, 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 lead, which has four electrodes to offer maximum flexibility for different pacing configurations to help manage heart failure patients. Despite advances in quadripolar pacing technology, non-responders to CRT therapy continue to be a clinical concern. The MultiPoint Pacing technology has been shown to enhance patients’ response to CRT. The technology allows physicians the opportunity 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.

“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, 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 bi-ventricular pacing therapy, which accounts for approximately one third of the total population of patients receiving CRT. With more options to treat patients who don’t respond to CRT, the clinician can reduce the rate of CRT non-responders and reduce the likelihood of costly lead revision through a second intervention procedure.

The new Quadra Allure MP CRT-P with MRI labeling is also compatible with the SyncAV™ CRT software, designed to build upon the MultiPoint Pacing technology and further optimize St. Jude Medical’s comprehensive CRT portfolio. The SyncAV CRT technology, 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.

Quadripolar technology offers physicians more options to manage heart failure and facilitates additional pacing configurations within the heart that offer physicians options not available in traditional bipolar systems.

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



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