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St. Jude Medical Receives FDA Approval for the World’s Smallest Upgradeable MR-Conditional Spinal Cord Stimulation System

April 30, 2015 9:07 AM EDT

New approval for the Protégé MRI system ensures patient access to upgradeable technology while removing a traditional barrier to SCS therapy

ST. PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, today announced FDA approval of the company’s Protégé MRI™ spinal cord stimulation system. In addition to the approval of the new Protégé MRI system, St. Jude Medical has also secured FDA approval for MRI compatibility of the company’s 60cm Octrode™ percutaneous leads, which has received MR-conditional labeling for use with the Protégé MRI system.

Image of the St. Jude Medical Protege MRI implantable pulse generator (IPG). The Protege MRI is the smallest MR-conditional upgradeable SCS IPG available in the U.S. (Photo: Business Wire)

The Protégé MRI system is the smallest MR-conditional SCS implantable pulse generator (IPG) available in the United States, and the only upgradeable IPG on the market to allow patients to safely undergo head and extremity MRI scans. Upgradeable technology allows patients to access future SCS technology from St. Jude Medical, once approved, through software updates rather than surgical device replacement. Historically, most patients would need additional surgery to receive new product features and benefits.

“The launch of the Protégé MRI system provides physicians with a solution that offers the benefits of future therapy upgrades as they are approved without the need for a future surgery,” said Robert Levy, M.D., Ph.D., director of the Marcus Neuroscience Institute in Boca Raton, Florida. “The Protégé MRI system is an innovative technology advancement that optimizes chronic pain care without compromising a patient’s potential need for future head and extremity MRI scans.”

Chronic pain affects more than 100 million Americans, an incidence rate which outpaces heart disease, cancer and diabetes combined. In total, the condition costs the American population 515 million workdays annually and generates upwards of 40 million visits to physicians each year.

SCS therapy can offer proven, meaningful chronic pain relief for many patients while improving quality of life and reducing or even eliminating a patient’s use of pain medication. Yet for some patients battling chronic pain, the possible need for future MRI scans has acted as a barrier to SCS therapy.

“With the approval of the Protégé MRI system, St. Jude Medical has helped remove a barrier for some patients who may benefit from SCS therapy, while preserving the ability of those patients to access future technology and therapy advancements wirelessly through upgradeable technology,” said Eric S. Fain, M.D., group president of St. Jude Medical. “Going forward, patients implanted with a Protégé MRI system will not only have the ability to access future upgrades, but will also have the ability to undergo head and extremity MRI scans.”

In addition to the approval of the Protégé MRI system, St. Jude Medical also plans to seek updated labeling in key markets around the world for several existing products, including their flagship Penta™ paddle lead, in order to allow more patients the ability to safely undergo MRI scans. St. Jude Medical also plans to submit testing data supporting full-body MRI conditional scan labeling for future SCS systems.

About the St. Jude Medical Chronic Pain PortfolioChronic 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 offers multiple solutions for patients to manage debilitating chronic pain, including spinal cord stimulation (SCS), radiofrequency ablation and peripheral nerve stimulation (PNS).

Spinal cord stimulation is a proven therapy used to manage chronic pain. SCS therapy uses a small implanted generator to deliver electrical pulses to the nerve fibers of the spinal column via thin wires, knows as leads, with electrodes. These electrical pulses mask or interrupt pain signals as they travel up the spinal cord to the brain, reducing the sensation of pain.

About St. Jude MedicalSt. 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 StatementsThis 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. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance

St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
[email protected]
Justin Paquette, 651-756-6293
Public Relations
[email protected]

Source: St. Jude Medical, Inc.

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