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Long Term Data Confirms the St. Jude Medical Axium System Delivers Sustained and Superior Pain Relief for Patients with Chronic Lower Limb Pain

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced long term data from the ACCURATE study has confirmed dorsal root ganglion (DRG) stimulation with the St. Jude Medical Axium™ Neurostimulator System provides sustained and superior pain relief over traditional spinal cord stimulation (SCS) in patients with complex regional pain syndrome (CRPS) or peripheral causalgia (PC). In addition, patients receiving DRG stimulation reported better therapeutic targeting and a reduction in paresthesia (the tingling feeling common to traditional SCS) compared to traditional tonic SCS.

The data were presented today during a plenary session at the 19th annual meeting of the North American Neuromodulation Society (NANS) in Las Vegas, Nevada, and confirm three month primary endpoint data originally presented at the International Neuromodulation Society (INS) annual meeting in June 2015.

“DRG stimulation represents hope to many patients eager for more meaningful treatment options for complex and hard-to-treat neuropathic chronic pain conditions,” said Robert Levy, M.D., director of the Marcus Neuroscience Institute in Boca Raton, Florida, and co-principal investigator of the ACCURATE study. “The data from the ACCURATE study have shown us that DRG stimulation yields long term meaningful pain relief for patients with complex regional pain syndrome and peripheral causalgia. The results of this trial are very exciting for those of us who treat patients with these debilitating conditions.”

Long-term, 12-month data from the ACCURATE study showed DRG stimulation offered patients:

  • Sustained and superior pain relief: After 12 months, the ACCURATE study demonstrated a statistically significantly number of patients receiving DRG stimulation achieved meaningful pain relief and greater treatment success when compared to patients receiving traditional SCS (74.2 percent vs. 53 percent) .
  • Improved therapeutic targeting: Nearly all patients receiving DRG stimulation reported better stimulation targeting in their area of pain without extraneous paresthesia than patients receiving traditional SCS (94.5 percent vs. 61.2 percent).
  • Reduced paresthesia: After 12 months, more than a third of patients who received DRG stimulation were experiencing greater than 80 percent pain relief with no paresthesia.

“The long term data from the ACCURATE trial further confirm that DRG stimulation with the St. Jude Medical Axium system can provide sustained and superior outcomes for patients suffering from chronic pain conditions that are currently very challenging to treat using traditional spinal cord stimulation,” said Allen Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “Patients battling complex regional pain syndrome and peripheral causalgia have very few options, and we believe DRG stimulation will provide a meaningful treatment option to patients suffering from these conditions.”

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 has suggested 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.

Neuropathic pain represents one of the most prevalent yet under-treated forms of chronic pain in the U.S., with an estimated one in every 10 adults over the age of 30 suffering from the condition. By targeting the DRG, a spinal structure densely populated with sensory nerves that transmit information to the brain via the spinal cord, the St. Jude Medical Axium system has been shown to provide pain relief to patients with neuropathic conditions currently underserved by traditional SCS.

The ACCURATE study represents the largest study to date evaluating patients suffering from neuropathic chronic lower limb pain associated with CRPS or PC. St. Jude Medical submitted their premarket approval (PMA) submission to the FDA for approval of DRG stimulation in Q1 2015. The Axium Neurostimulator System has been available in Europe since 2011.

Additionally, St. Jude Medical will be hosting an investor event at the NANS Conference Friday, December 11th starting at 3:00pm PST. The event will include a presentation highlighting St. Jude Medical’s Neuromodulation portfolio and clinical data presented at NANS followed by a Q&A period. A live webcast of the event will also be available via the Investor Relations section of the St. Jude Medical website (http://investors.sjm.com/ ).

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 chronic pain therapy solutions and 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.

*Caution: Investigational device. Limited by Federal law to investigational use.

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.

Contact:

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

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