St. Jude Medical Announces MHLW Approval for MRI Conditional Labeling on Quadra Assura CRT-D to Improve Access to Diagnostic Imaging for Heart Failure Patients

Tokyo, Japan ., Jude Medical Japan Co., Ltd., a medical device company, today announced approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for magnetic resonance (MR) conditional labeling for the company’s Quadra Assura^™ Cardiac Resynchronization Therapy Defibrillator (CRT-D). With the updated approval, the Quadra Assura™ CRT-D is now approved for use with magnetic resonance imaging (MRI) scanning systems with strength of 1.5 Tesla (measurement for the strength of a magnetic field).

Through the approval for the MRI conditional labelling, patients with the device will be now able to undergo MRI scans under fixed conditions. This has a significant meaning for patients’ quality of life.

“The Quadra Assura CRT-D MRI allows both newly implanted patients and patients who have an existing Quadra Assura device to get an MRI scan under certain conditions. This provides a significant benefit for both patients who have already received biventricular pacing treatment by left ventricular quadripolar pacing technology and those who will be treated going forward,” said Dr. Takeshi Mitsuhashi, an associate professor of Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University. “This means that diagnosis limitations of MRI scan, which were conventionally restricted, will be less restrictive without compromising decisions on treatment.”

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. Cardiac resynchronization therapy coordinates the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure (HF) patients. Approximately 23 million people worldwide are afflicted with congestive HF and 2 million new cases are diagnosed each year worldwide.

The Quadra Assura CRT Systems have been shown to demonstrate an improvement in quality of life and reduce hospitalization rates by 53 percent. Heart failure 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 lead technology. 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 Mark Carlson, M.D., chief medical officer and vice president of global clinical affairs at St. Jude Medical. “We remain committed to being the leader in quadripolar technology while continuing to focus on improving patients’ quality of life.”

Source: ST. Jude Medical