St. Jude Medical Receives CE Mark for the New Infinity Deep Brain Stimulation System and Directional DBS Lead

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE Mark approval for the St. Jude Medical Infinity™ Deep Brain Stimulation (DBS) System and directional DBS lead. The St. Jude Medical Infinity DBS system, which will be available in two sizes, is the only upgradeable DBS system available to patients battling movement disorders. The system uses Bluetooth® wireless technology to communicate between the St. Jude Medical Infinity DBS platform and Apple™ digital devices used as patient and physician controllers. Combined, the features of the system provide an improved, more intuitive experience for patients suffering from Parkinson’s disease, tremor and dystonia, a disorder which causes involuntary muscle contractions.

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Movement disorders are neurologic conditions that develop as communications breakdown throughout a patient’s central nervous system, leading to a debilitating lack of muscle control, involuntary movement, and reduced coordination. With no proven cure, treatments for movement disorders often focus on alleviating the symptoms associated with each condition to improve quality of life. Combined, Parkinson’s disease, dystonia and tremor represent the three most common movement disorders in the world.

DBS systems deliver mild electrical pulses to specific targets in the brain to stimulate the structures involved in motor control. The systems consist of a surgically-implanted neurostimulator that generates the electrical pulses and thin wires called leads which carry the pulses to the brain to influence the irregular nerve signals responsible for many of the symptoms of movement disorders.

Conventional DBS leads have a limited ability to steer current directionally, which can be challenging for physicians trying to provide effective stimulation to specific areas of the brain. The St. Jude Medical Infinity DBS system operates in conjunction with the company’s newly-approved directional DBS lead, which allows physicians to shape the therapy to a patient’s specific needs while avoiding stimulation to areas that may create side effects. St. Jude Medical designed the Infinity platform and directional lead based on physician feedback demonstrating a clear need for improved stimulation targeting, device longevity and a maintenance free, non-rechargeable battery.

“The Infinity DBS system, including our directional lead and wireless technology, represents a major step forward in our DBS product portfolio, demonstrating St. Jude Medical’s commitment to patient-centric solutions to help alleviate the debilitating effects of movement disorders,” said Eric Fain, M.D., group president at St. Jude Medical. “Not only are we able to offer therapy solutions for a broad set of indications for movement disorders, but we’ve also designed the system to provide patients the best possible experience with their therapy while helping physicians manage their patients more efficiently and effectively.”

According to the European Brain Council, 1.2 million Europeans suffer from Parkinson’s disease. Other statistics indicate that more than 500,000 people battle some form of dystonia and an estimated 14 percent of people over 65 suffer from essential tremor, the most common form of tremor.

The St. Jude medical Infinity DBS system was designed to transform the standard of care for movement disorder patients by incorporating a number of patient-centric features. Because the Infinity system is upgradeable, St. Jude Medical offers patients the ability to retain access to the latest technology and therapy options and new modes of stimulation as they are approved via software upgrades, avoiding the need to undergo repeat surgery. St. Jude Medical has also developed technology to allow patients with existing DBS systems from any manufacturer to replace their existing system to take advantage of the advancements enabled by the Infinity system.

In addition, patients will now be provided an Apple iPod Touch™ digital device that allows them to easily manage their therapy. Physicians will program their patient’s devices through an iPad Mini™ digital device. The St. Jude Medical patient and physician programmers use Bluetooth® wireless technology, providing a secure, safe, and wireless experience.

“The new St. Jude Medical Infinity DBS system is enabling physicians to improve management of our patient’s symptoms so we can tailor our therapy approach and provide optimal treatment solutions unique to the patient,” said Dr. Jan Vesper, a professor of functional neurosurgery and stereotaxy at Heinrich Heine University in Dusseldorf, Germany, and president of the German Neuromodulation Society. “In addition to the benefits associated with the new Infinity platform, with the St. Jude Medical directional lead physicians will have access to a tremendous leap forward in technology that has the potential to support improved patient outcomes and potentially reduce side effects.”

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 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 July 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.

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Contact information

St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
jweigelt@sjm.com
or
Barbara Van Buyten, +32 473 55 34 82
Media Relations
bvanbuyten@sjm.com