St. Jude Medical Announces CE Mark for MRI Compatibility on Quadra Assura CRT-D to Improve Access to Diagnostic Imaging for Heart Failure Patients

ST. PAUL, Minn., St. Jude Medical, Inc., a global medical device company, today 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 QuadraAssura™ CRT-D and Quadra Assura MP™ CRT-D with MultiPoint™ Pacing are now approved for use with magnetic resonance imaging (MRI) scanning systems with strength up to 1.5 Tesla (measurement for the strength of a magnetic field).

“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 Dr. Giovanni Forleo, 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 industry’s only MultiPoint Pacing technology on a single left ventricular lead, and is an innovation 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 St. Jude Medical™ Quadra Assura CRT-D MRI offers the CRT-D device with 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. 

“Adding MRI availability to our market-leading quadripolar technology advances options for patients and ensures future access to diagnostic imaging they may need in their heart failure treatment,” said Eric S. Fain, M.D., group president at St. Jude Medical. “We remain committed to being the leader in quadripolar technology while continuing to focus on improving patients’ quality of life.” 

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

Source: St. Jude Medical