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St. Jude Medical (STJ)'s Spinal Cord Device Wins New Labeling From the FDA



11/14/2016 7:21:36 AM

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St. Jude Medical Announces Full-Body MRI Compatibility and Second Major Upgrade for Proclaim Elite Spinal Cord Stimulation System

New labeling ensures patients in need of future full-body MRIs can have access to the recharge-free Proclaim Elite SCS System and the company’s proprietary BurstDR stimulation technology

ST. PAUL, Minn.--()--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. Food and Drug Administration approval for full-body magnetic resonance (MR) Conditional labeling for the Proclaim™ Elite Spinal Cord Stimulation (SCS) System. With the latest labeling approval, patients who receive the Proclaim Elite SCS system can now undergo full-body magnetic resonance imaging (MRI) diagnostic scans within approved parameters and access the benefits of BurstDR™ stimulation therapy.

“This MR Conditional labeling applies to both new patients and those already implanted with the upgradeable Proclaim Elite SCS System,” said Dr. Thomas L. Yearwood of Comprehensive Pain & Rehabilitation in Pascagoula, Mississippi. “I am very grateful that I can now safely expand access to the superior therapeutic outcomes offered by BurstDR stimulation to my patients who may need a full-body MRI in the future.”

Full-body MRI compatibility is the second major upgrade to the Proclaim Elite SCS system following the recent approval of BurstDR stimulation. Current and future patients who get the Proclaim Elite SCS system will now have access to both full-body MRI scans within approved parameters and BurstDR stimulation. St. Jude Medical designed the Proclaim Elite SCS system to offer patients future approved upgrades through software updates without the need to surgically replace their device.

St. Jude Medical’s proprietary BurstDR stimulation works differently from other stimulation designs, utilizing intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns. BurstDR stimulation is a physician-designed form of SCS clinically proven to provide patients superior pain relief (as compared to tonic stimulation) by reducing their physical pain and addressing their emotional response to pain as measured by visual analogue scale (VAS) scoring. Physicians nationwide have begun to offer their patients access to BurstDR stimulation.

“The addition of full-body MR Conditional labeling for the Proclaim Elite SCS system will be another critical benefit for my patients and will help me ensure those who may one day need an MRI can benefit from St. Jude Medical’s innovations without fear of putting themselves and their implant at risk,” said Dr. Steven M. Falowski, chief of functional neurosurgery at St. Luke's University Health Network in Bethlehem, Pennsylvania.

The Proclaim Elite SCS System was the first upgradeable, recharge-free system available to people in the U.S. suffering from chronic pain. The system’s Bluetooth® wireless technology allows patients to control and adjust their SCS therapy with an Apple™ iPod touch™ mobile digital device. St. Jude Medical designed many elements of the Proclaim system based on physician and patient feedback, such as removing the burden of regularly recharging the SCS system.

“Today, physicians treating patients with chronic pain need new therapy options that consistently put the patient first and ensure minimal disruption to their daily life,” said Allen W. Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “Historically, the need for future MRI scans could act as a barrier to patients who may benefit from SCS therapy. Our new labeling for the Proclaim Elite SCS system ensures that patients can receive BurstDR stimulation while having the peace of mind knowing their SCS system can be safely scanned with diagnostic imaging.”

According to the Institute of Medicine, chronic pain affects more than 100 million Americans, an incidence rate which outpaces heart disease, cancer and diabetes combined. Past research has suggested that the condition can cost the American population an estimated 515 million workdays annually and generates upwards of 40 million visits to physicians each year. Many patients suffering from chronic pain may ultimately need an MRI in the future.

Note: Apple, iPod touch and iPad Mini are trademarks of Apple, Inc. Bluetooth is a trademark of Bluetooth SIG, Inc.

About St. Jude Medical

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 employs approximately 18,000 people worldwide and has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management and cardiovascular. 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, reimbursement strategies, 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 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended October 1, 2016. The company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Contacts

St. Jude Medical, Inc.
Investor Relations:
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations:
Justin Paquette, 651-756-6293
jpaquette@sjm.com


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