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St. Jude Medical Announces FDA Approval of the Proclaim Elite SCS System

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St. Jude Medical Announces FDA Approval of the Proclaim Elite SCS System

Image provided courtesy of St. Jude Medical, Inc.


ST. PAUL, Minn.–(BUSINESS WIRE)– St. Jude Medical, Inc. (NYSE:STJ), a global medical device company and an international leader in chronic pain therapy development, today announced FDA approval of the new Proclaim™ Elite Spinal Cord Stimulation System, the first and only upgradeable and recharge-free spinal cord stimulation (SCS) system available to people in the U.S. suffering from chronic pain. The approval also includes conditional magnetic resonance (MR) labeling for the Proclaim Elite SCS system, which will allow patients to safely undergo head and extremity MRI scans.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20151119005155/en/

The current approval also includes the company’s new, innovative clinician programmer, which allows clinicians to program and adjust their patient’s spinal cord stimulation therapy with an Apple™ iPad mini™ mobile digital device. In addition, patients will be able to evaluate spinal cord stimulation with the St. Jude Medical™ Invisible Trial System, a discreet, app-based and wireless neuromodulation programming system leveraging Apple™ iPod touch™ mobile digital devices.

The approval of the Proclaim Elite recharge-free SCS system is a needed advancement for both patients and physicians who now have access to a low-maintenance chronic pain treatment that can reduce interference with daily activities,

said Timothy R Deer, M.D., president and chief executive officer ofThe Center for Pain Relief in Charleston, West Virginia.

In the last 10 years of SCS, we have seen advances in rechargeable technology but less attention paid to therapy compliance and how patients interact with their device. Now with the Proclaim Elite SCS system we can offer appropriate patients an optimal low-maintenance experience while enabling access to future therapies without the need for additional surgeries.

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.

St. Jude Medical designed many elements of the Proclaim system based on physician and patient feedback to ensure patients could benefit from all aspects of the product. In particular, the non-rechargeable system improves patient convenience by removing the burden of regularly recharging the SCS system. The system’s upgradable platform allows patients to access future SCS technology upgrades, such as new stimulation waveforms and software updates, without surgical device replacement. Historically, most patients would need additional surgery to receive product upgrades as they are approved.

With its latest round of SCS product offerings, St. Jude Medical aims to further enhance ease-of-use and familiarity for patients by leveraging Bluetooth® wireless technology and Apple™ mobile digital devices for the Proclaim Elite SCS system’s patient controller and clinician programmer. This approach will allow patients to interact with their device more easily, which can ensure effective management of their chronic pain treatment with minimal disruption to their daily life.

St. Jude Medical has a legacy of consistently advancing spinal cord stimulation therapy options to our ensure chronic pain patients are receiving innovative, patient-centric devices and optimal therapy to manage their chronic pain,

said Allen Burton, M.D., medical director of neuromodulation at St. Jude Medical.

The new St. Jude Medical Proclaim Elite system bridges the gap between today’s state-of-the-art therapies and tomorrow’s groundbreaking innovations for chronic pain. The wireless platform is based on the latest Apple technologies making it upgradeable to new therapies for the future. With a discreet, hassle-free trial system and a simple permanent implant procedure, this pioneering platform can improve both the patient’s chronic pain and overall therapy experience.

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


About the St. Jude Medical Chronic Pain Portfolio
Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can negatively impact personal relationships, work productivity and a patient’s daily routine. St. Jude Medical is an international leader in the development of innovative chronic pain therapeutic options and offers multiple solutions for patients to manage debilitating chronic pain, including spinal cord stimulation, spinal cord stimulation targeting the DRG and radiofrequency ablation.


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 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, 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 October 3, 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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20151119005155/en/

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