St. Jude Medical Japan Obtains MHLW Approval for MRI Compatibility on Ellipse™ ICD to Improve Patient Access to Diagnostic Imaging

The approval of expanded labelling further expanding St. Jude Medical’s MRI-compatible device portfolio

St. Jude Medical Japan Co., Ltd., a medical device company, today announced approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) of expanded labelling for its EllipseTM implantable cardioverter defibrillator (ICD) allowing existing or future patients with the technology to undergo magnetic resonance imaging (MRI) scans. EllipseTM ICD will be launched on March 1st, 2016. The approval further expands St. Jude Medical’s MRI-conditional device portfolio in Japan.

Through the approval for the MRI compatible 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.

“St. Jude Medical is committed to providing MRI-compatible solutions for its ICD and pacemaker devices for patients and physicians worldwide,” said Eric S. Fain, M.D., group president of St. Jude Medical. “These products are already proven cardiac rhythm management technologies and now, due to extensive research and testing, they are available in the MRI environment. We will continue to develop advanced MRI-compatible technologies in order to ensure patient access to this important diagnostic tool.”

Dr. Kengo Kusano, from the Division of Arrhythmia, National Cerebral and Cardiovascular Center, says that “ICDs play an important role for patients suffering from fatal arrhythmia because they provide life-saving defibrillation therapy. Therefore, patients with an elevated DFT (Defibrillation Threshold) benefit from having an ICD implant to ensure appropriate management of therapy that manage high DFT (Defibrillation Threshold: patients who require large amounts of energy to shock the heart back to a normal rhythm) and reduce potential risk of defibrillation lead failure. Now with MRI compatibility added to these life-saving features, these ICDs will provide even more additional benefits to Japanese patients moving forward.”

Designed to offer patients added protection in the event of a life-threatening arrhythmia, the Ellipse ICD is among the smallest and most advanced today. The device uses the company’s DynamicTx™ Over Current Detection Algorithm, which automatically adjusts shocking configurations for patients in order to ensure the delivery of high-voltage therapy if an electrical short occurs in one part of the system. The Ellipse ICD also utilizes DeFT Response™ technology, allowing for physicians to customize the amount of energy delivered for each individual patient, in addition to low friction coating on the device can. The added coating has been demonstrated in testing to significantly reduce the friction between the device and leads, potentially reducing lead-to-can abrasion, which is one of the most common types of insulation failure in the industry. Ellipse is supported by Merlin.netTM Patient Care Network (PCN) for patient management through remote monitoring. This remote monitoring system helps physicians to accurately perform the treatment using the device and correctly understand patients’ conditions after the treatment. It is also expected to contribute to the early detection of atrial fibrillation related events as well as the decreased hospitalizations*7 in relation to cardiac failure. 

In the coming months, St. Jude Medical anticipates updated labeling for many of its existing cardiac rhythm management devices, which will allow more patients the ability to safely undergo MRI scans.

About St. Jude Medical (this is the Japanese version with the global legal approval)
St. Jude Medical is a leading global medical device manufacturer and is 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 five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management, and cardiovascular diseases

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