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The CLIK X  MRI anchor is streamlined to support the lead transition into the fascia with Quick, Simple, and Secure lead anchoring. this anchor is constructed with radiopaque material so it can easily be identified as an MRI Conditional System when imaged.


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St. Jude Medical Announces FDA Approval of a New Treatment Therapy for Patients Suffering From Chronic Intractable Pain

02/17/2016

Dorsal root ganglion (DRG) stimulation aims to provide pain relief for patients with chronic intractable pain conditions due to complex regional pain syndrome I and II

ST. PAUL, Minn.–(BUSINESS WIRE)– St. Jude Medical, Inc. (NYSE:STJ), a global medical device company and an international leader in the development of therapies for the treatment of chronic pain, today announced FDA approval of the St. Jude Medical Axium™ Neurostimulator System for dorsal root ganglion (DRG) stimulation. The approval of DRG stimulation in the U.S. will ensure access to a superior therapeutic approach for treating moderate to severe chronic intractable pain of the lower limbs in adult patients with complex regional pain syndrome (CRPS I and II). The chronic pain disorder known as CRPS often affects the extremities. St. Jude Medical expects that DRG stimulation will be available to physicians and patients in the coming months.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20160217005447/en/

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. 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 stimulating 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 delivers a form of spinal stimulation that gives physicians the ability to treat the specific areas of the body where pain occurs. As a result, DRG stimulation is a first-of-its-kind therapeutic approach that provides pain relief to patients with neuropathic conditions underserved by traditional SCS who have tried multiple treatment options without receiving adequate pain relief.

“The approval of St. Jude Medical’s DRG neurostimulation system represents an exciting new option for me to deploy in the fight against the focal and intractable chronic pain syndromes facing my patients every day,” said Dr. Timothy Deer, an interventional pain physician, president and CEO of the Center for Pain Relief in Charleston, West Virginia. “For the large and growing numbers of under-treated patients suffering from complex regional pain syndromes – like those resulting from total knee arthroscopy, foot surgery or hernia surgery – DRG stimulation can offer improved, long-lasting relief.”

Approval of DRG stimulation with the St. Jude Medical Axium system was based in part on the results of the ACCURATE IDE study, the largest study to date evaluating patients suffering from neuropathic chronic intractable pain associated with CRPS I and II or peripheral causalgia (PC). Patients in the study were randomized to receive either DRG stimulation delivered by the Axium Neurostimulator System or traditional tonic SCS therapy delivered by a competitor’s system. At both three-month and 12-month intervals, results from the ACCURATE study showed DRG stimulation provided patients with superior pain relief over traditional tonic SCS.

“St. Jude Medical is focused on providing physicians with more options to treat patients suffering from a wide range of chronic pain conditions, no matter where in the body the patient may experience pain,” said Allen Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “The addition of DRG stimulation to our portfolio demonstrates our continued commitment to ensuring physicians have the broadest range of meaningful chronic pain therapy options.”

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 the St. Jude Medical Neuromodulation Portfolio

Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can negatively impact mood, personal relationships, work productivity, and activities of daily living. St. Jude Medical is the only medical device company that offers multiple solutions for patients to manage debilitating chronic pain, including spinal cord stimulation (SCS), dorsal root ganglion (DRG) and radiofrequency ablation (RFA). St. Jude Medical is also a pioneer in developing cutting-edge deep brain stimulation (DBS) technologies for the treatment of movement disorders.

About St. Jude Medical

St. Jude Medical is a leading global medical device manufacturer and is 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 five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management, and cardiovascular diseases. 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.

Source: St. Jude Medical, Inc.

St. Jude Medical, Inc.

J.C. Weigelt, 651-756-4347

Investor Relations

jweigelt@sjm.com

Laurel Hood, 651-756-2853

Media Relations

lhood02@sjm.com


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HF10TM THERAPY: DEVELOPED THROUGH BEST-IN-CLASS CLINICAL EVIDENCE

Neuromodulation has been used for decades to treat chronic pain. Yet despite its widespread adoption, limited published, prospective, long-term evidence about the efficacy of traditional spinal cord stimulation (SCS) existed. Nevro understands the critical importance of clinical evidence in today’s environment and has produced world class evidence to advance SCS therapy. No other company has committed so fully to establishing clinical evidence of the safety and efficacy of SCS treatment and no other SCS technology has the wealth of clinical study data to back its technology.

SENZA-RCT: A first-of-its-kind study

THE FIRST MULTICENTER, PROSPECTIVE, RANDOMIZED, CONTROLLED PIVOTAL STUDY OF AN SCS SYSTEM.

First randomized, pivotal study of an SCS system

  • Largest RCT study for back pain and leg pain: 241 participants enrolled, 198 randomized, 171 implanted

First study to directly compare SCS technologies

  • HF10™ therapy compared to traditional SCS

First RCT study to enroll patients with BOTH back pain and leg pain

  • Inclusion criteria required VAS of ≥5 for BOTH back pain and leg pain

First SCS study to report on 100% of patients to 12 months

  • 171 implanted patients followed to 12 months

HF10TM Therapy: Labeled as Superior to Traditional SCS for Back Pain and Leg Pain

HF10 therapy was labeled superior to traditional SCS due to the rigor and outcomes of the SENZA-RCT. The study demonstrated superiority at all primary and secondary endpoints vs traditional SCS.

MORE PATIENTS

HF10™ therapy delivered superior back pain and leg pain response.

MORE PAIN RELIEF

HF10 therapy delivered superior reduction in both back pain and leg pain at all measured time points.

WITH NO PARESTHESIA

HF10 therapy is the only SCS therapy indicated as paresthesia-free.

  • Eliminates restrictions on driving and sleeping
  • Improves patient satisfaction

The Senza® system: Superior outcomes delivered through best-in-class technology

  • The only IPG indicated to deliver paresthesia-free therapy
  • The only SCS system that is 1.5 and 3 Tesla MRI compatible for head and extremity scans
  • The only IPG with 10-year-plus battery life at 10 kHz
  • The only IPG that can provide HF10 therapy

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RestoreSensor SureScan MRI Neurostimulator


 

FOR SPINAL CORD STIMULATION

RestoreSensor® SureScan® MRI neurostimulator automatically adjusts stimulation based on the patient’s needs and preferences in different body positions. AdaptiveStim® automatically recognizes and remembers the correlation between a change in body position and the patient’s programmed settings.

Only AdaptiveStim technology provides personalized pain management through a variety of low density (LD) and high density (HD) programming options. It automatically adjusts amplitude, pulse width and electrode configurations to maintain optimal therapy energy – at any density.

RestoreSensor SureScan MRI allows patients safe* access to MRI scans anywhere in the body. Medtronic SureScan MRI Technology eliminates the need to perform an inconvenient and costly explantation whenever the need for an MRI scan arises


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