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. Jude Medical, Inc. (NYSE:STJ), 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 Quadra Assura™ 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.

About St. Jude Medical’s Heart Failure Portfolio

As a leader in heart failure disease management, St. Jude Medical is pioneering innovative solutions like the CardioMEMS^™ HF System, ground-breaking quadripolar technology, our first-to-market MultiPoint pacing technology in select markets, and the HeartMate 3^™ left ventricular assist system in select European markets. St. Jude Medical collaborates with heart failure specialists, clinicians and advocacy partners to provide innovative, cost-effective solutions that help reduce hospitalizations and improve patient quality of life for heart failure patients around the world.

For more information about St. Jude Medical’s focus on heart failure, visit the St. Jude Medical Heart Failure Media Kit or the St. Jude Medical PULSE Blog.

Information for patients to learn more about heart failure can be found at heartfailureanswers.com.

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended January 3, 2015 and Quarterly Report on Form 10-Q for the fiscal quarter ended October 3, 2015. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: http://www.businesswire.com/news/home/20151202005398/en/

Contact information

St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
jweigelt@sjm.com
or
Kristi Warner, 651-756-2085
Media Relations
kwarner@sjm.com