Recent CE Mark approvals expand St. Jude Medical’s MRI-compatible device portfolio in Europe

May 14 2015

CE Mark approvals further strengthen the company’s portfolio of MRI-compatible devices

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE Mark approval of expanded labelling for its Ellipse™ implantable cardioverter defibrillator (ICD), in addition to its Durata™ and Optisure™ defibrillation leads, allowing existing or future patients with these technologies to undergo magnetic resonance imaging (MRI) scans without compromising device performance. The company also announced today that it has received CE Mark approval for its Assurity MRI™ and Endurity MRI™ pacemaker device families. The approvals further expand St. Jude Medical’s MRI-conditional device portfolio in Europe.

“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.”

Designed to offer patients added protection in the event of a life-threatening arrhythmia, the Ellipse device is among the smallest and most advanced ICDs today. The device uses the company’s DynamicTx™ 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.

“It’s not uncommon for patients with cardiac devices to have an unrelated medical need for an MRI scan over the lifetime of their device,” said Amir Zaidi, M.D., consultant cardiologist at the Manchester Royal Infirmary in Manchester, U.K. “The growing availability of MRI-compatible technologies offered by St. Jude Medical is significant for patients, because it now means they will have access to this important diagnostic tool without compromising their device performance.”

The Assurity MRI and Endurity MRI devices are the world’s smallest, longest-lasting wireless pacemakers available to patients today. These devices allow early notification of atrial fibrillation-related events and pacing that helps reduce heart failure-related hospitalizations. Both pacemakers are supported by the Merlin.net™ Patient Care Network (PCN) website for remote patient management.

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. St. Jude Medical is planning to submit test data in key markets around the world in 2015 for MRI conditional labeling on additional existing high-voltage products including the Fortify™ Assura ICD, Quadra Assura CRT-D, and Quartet LV leads.