[June 08, 2015]

St. Jude Medical's Axium System Found to Provide Superior Pain Relief Over Traditional Spinal Cord Stimulation for the Treatment of Chronic Lower Limb Pain

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced data from the ACCURATE Study shows that stimulation of the dorsal root ganglion (DRG) with the St. Jude Medical Axium™ Neurostimulator System is associated with superior pain relief over traditional spinal cord stimulation (SCS (News - Alert)) for the treatment of chronic pain of the lower limbs.

The ACCURATE study, which is designed to support U.S. approval of DRG stimulation, represents the medical device industry's largest study to date to evaluate patients suffering from chronic lower limb pain associated with complex regional pain syndrome (CRPS) or peripheral causalgia (nerve damage); two of the many chronic pain conditions currently underserved by traditional SCS therapy. Neuropathic pain represents one of the most prevalent yet under-treated chronic pain conditions currently facing U.S. patients. A total of 152 patients were enrolled in the trial at 22 centers across the United States.

Patients in the study were randomized to receive either DRG stimulation delivered by the Axium Neurostimulator System or traditional SCS therapy delivered by a competitor's system. After three months, investigators from the ACCURATE study found the trial had met its primary endpoints for both non-inferiority and superiority over traditional SCS. Specifically, data from the ACCURATE study shows DRG stimulation delivered:

• Superior pain relief: Significantly more patients receiving DRG stimulation achieved significant pain relief and greater treatment success when compared to patients receiving traditional SCS (81.2 percent vs 55.7 percent).
• Consistent therapy: Patients receiving DRG stimulation reported no differences in paresthesia intensity due to changes in body position (known as postural effects) when compared to traditional SCS. A statistically significant result was found between the two groups studied. Postural effects can be a common challenge associated with traditional SCS therapy.
• Precise Anatomical Coverage: Patients in the Axium group were significantly less likely to report feeling stimulation outside their area of pain, compared to the control group.

"Data from the ACCURATE Study are exciting because they demonstrate that DRG stimulation can offer meaningful improvement over traditional spinal cord stimulation for patients suffering from chronic pain conditions that have historically been challenging to treat," said Mark Carlson, M.D., chief medical officer at St. Jude Medical. "We look forward to continuing to develop DRG stimulation therapy to expand availability for patients currently underservd by traditional chronic pain therapy options."

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. Research suggests that, in total, the condition costs the American population an estimated 515 million workdays annually and generates upwards of 40 million visits to physicians each year.

Stimulation of the DRG with the St. Jude Medical Axium system targets nerves within the DRG, a spinal structure packed with sensory nerves that transmit information to the spinal cord, which then conducts those signals to the brain. By targeting the DRG, stimulation with the Axium system has been shown in international research to be effective in treating conditions currently underserved by traditional SCS. St. Jude Medical plans to explore potential pathways to further expand the availability of DRG stimulation for other hard-to-treat chronic pain conditions.

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 the only medical device manufacturer in the world to offer radiofrequency ablation (RFA) and spinal cord stimulation (SCS) therapy solutions including Burst stimulation and stimulation of the dorsal root ganglion (DRG) for the treatment of chronic pain.

About the St. Jude Medical Axium Neurostimulator System

The Axium Neurostimulator System stimulates a spinal target called the dorsal root ganglion (DRG), which contains primary sensory neurons that transmit pain signals from nerves to the brain. DRG stimulation with the Axium system has been shown to be particularly effective for treating pain in areas currently underserved by traditional SCS, such as the groin, lower leg and feet. The Axium system originally received CE Mark approval in November 2011 for the management of chronic, intractable pain. The Axium system is also approved for use in Australia.

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 (News - Alert) @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 (News - Alert), 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.

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