Healthcare Industry News:  Assurity MRI 

Devices Cardiology Regulatory

 News Release - May 13, 2015

St. Jude Medical Expands Portfolio of MRI-Compatible Devices to High Voltage in Europe

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

ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)--St. Jude Medical, Inc. (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™ 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.

About Cardiac Rhythm Management Devices

An ICD is an advanced implantable device that treats potentially lethal, abnormally fast heart rhythms, which often lead to sudden cardiac death (SCD). A pacemaker is a small implantable device that sends electrical pulses to the heart if the heart is beating too slowly. Each year, more than one million pacemakers and 300,000 ICDs are implanted worldwide.

A lead is a thin insulated wire that is placed through the vein as part of a pacemaker or ICD implantation procedure. The tip of the lead is attached to the heart tissue, and the other end connects to the pacemaker or ICD. A lead carries electrical impulses from the pacemaker or ICD to the heart and transmits information from the heart back to the implanted device.

About St. Jude Medical’s Arrhythmia Business

St. Jude Medical's arrhythmia business, based in St. Paul, Minn., is one of the fastest growing divisions within St. Jude Medical. A leader in collaborating with world-renowned electrophysiologists, clinicians and hospital administrators, St. Jude Medical develops safe and cost-effective treatment solutions for patients in need of advanced cardiac rhythm devices.

For more information about St. Jude Medical’s focus on arrhythmia management, visit SJM newsroom/arrhythmias-stroke-prevention.

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 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 April 4, 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.

Source: St. Jude Medical

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