News | Cardiac Resynchronization Therapy Devices (CRT) | December 14, 2015

St. Jude Medical Gains MRI Compatibility CE Mark for Quadra Assura CRT-D

Approval will allow improved access to diagnostic imaging for heart failure patients

St. Jude Medical, Quadra Asssura CRT-D, Quadra Assura MP, MR conditional labeling, CE Mark

December 14, 2015 — St. Jude Medical Inc. announced CE Mark approval for magnetic resonance (MR) conditional labeling for the company’s currently approved Quadra Assura Cardiac Resynchronization Therapy Defibrillator (CRT-D). The Quadra Assura CRT-D and Quadra Assura MP CRT-D with MultiPoint Pacing are now approved for use with MRI scanning systems with strength up to 1.5 Tesla.

“The Quadra Assura CRT-D MRI allows patients to continue to be actively paced and continuously monitored with the quadripolar pacing technology while having the capability to get an MRI scan if needed,” said Giovanni Forleo, M.D., electrophysiologist at the University Hospital of Tor Vergata, Rome, Italy. “Being able to offer MRI-compatible technology without compromising care decisions is extremely important; this is yet another valuable tool for us to treat patients living with heart failure.”

CRT resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure (HF) patients. Studies have shown that CRT can improve the quality of life for many patients with HF, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. Approximately 23 million people worldwide are afflicted with congestive HF, and 2 million new cases are diagnosed each year worldwide.

The Quadra Assura CRT-D has been shown to demonstrate an improvement in quality of life and reduce hospitalization rates by 53 percent. The Quadra Assura MP CRT-D builds upon that improvement with the MultiPoint Pacing technology on a single left ventricular lead, demonstrated to improve patient response to therapy. HF patients implanted with these devices now have the reassurance of being able to receive an MRI if needed.

The Quadra Assura CRT-D MRI offers the CRT-D device with what the company calls first-to market quadripolar and next-generation Multipoint Pacing technologies, which enables physicians to pace multiple locations on the left side of the heart. This gives the clinician more choices to meet patient needs by optimizing CRT pacing to reduce the rate of CRT non-responders, as well as the likelihood of costly and invasive lead revision through a second interventional procedure.

MultiPoint Pacing is an investigational device and is not commercially available in the United States. MRI labeling is not approved in the U.S. or Australia for these devices.

For more information: www.sjm.com

Related Content

Left bundle branch (LBBP) activation imaging shown using wall motion color codes on echo imaging from Canon. #HRS2020 #heartrhythm2020

Left bundle branch (LBBP) activation imaging shown using wall motion color codes on dyamic echo imaging from Canon. 

News | Cardiac Resynchronization Therapy Devices (CRT) | May 13, 2020
May 13, 2020 —...
Valentina Kutyifa, M.D., Ph.D., University of Rochester Medical Center, Rochester, N.Y., is doing research in the BIO-LIBRA Study to determine it ICD or CRT-D devices work better in men or women with heart failure often present with non-ischemic cardiomyopathy.

Valentina Kutyifa, M.D., Ph.D., University of Rochester Medical Center, Rochester, N.Y., is doing research in the BIO-LIBRA Study to determine it ICD or CRT-D devices work better in men or women with heart failure often present with non-ischemic cardiomyopathy.

Feature | Cardiac Resynchronization Therapy Devices (CRT) | March 09, 2020 | Valentina Kutyifa M.D., Ph.D.
Cardiovascular disease is the leading cause of death for women in North America, and women with...
His Corrective Pacing Effective as an Initial Strategy for Heart Failure Cardiac Resynchronization CRT therapy vs. biventricular pacing (BiV) as a first-line strategy. #HRS #HRS19 #HRS2019
News | Cardiac Resynchronization Therapy Devices (CRT) | May 15, 2019 | Dave Fornell, Editor
May 15, 2019 — A pilot trial has shown His pacing in...
Biotronik Launches Acticor DX and CRT-DX Devices in U.S.
News | Cardiac Resynchronization Therapy Devices (CRT) | April 29, 2019
Biotronik announced the full commercial launch of the Acticor device family, including Acticor DX and CRT-DX devices....
Biotronik Launches Acticor and Rivacor ICD and CRT-D Devices in Europe
News | Cardiac Resynchronization Therapy Devices (CRT) | April 18, 2019
Biotronik announced the European market release of what it calls the world’s smallest implantable cardioverter...
Medtronic AdaptivCRT Feature Associated with Improved Heart Failure Patient Survival
News | Cardiac Resynchronization Therapy Devices (CRT) | May 22, 2018
Medtronic plc announced study results showing its AdaptivCRT algorithm is associated with improved patient survival....
Medtronic Recalls CRT-Ds and ICDs Due to Manufacturing Error Preventing Electrical Shock Delivery
News | Cardiac Resynchronization Therapy Devices (CRT) | February 26, 2018
The U.S. Food and Drug Administration (FDA) announced that Medtronic is recalling certain implantable cardioverter...
Abbott Announces MR-Conditional Labeling for Quadra Assura CRT-D and Fortify Assura ICD
Technology | Cardiac Resynchronization Therapy Devices (CRT) | January 03, 2018
Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for...
Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT) | August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...