Healthcare Industry News:  Neurostimulation 

Devices Neurology

 News Release - December 3, 2013

St. Jude Medical Launches US Study of New Prodigy Neurostimulator to Evaluate Burst Stimulation Technology for Chronic Pain

ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)--St. Jude Medical, Inc. (STJ), a global medical device company, has initiated a clinical study of the Prodigy™ neurostimulator, the first spinal cord stimulation (SCS) system able to deliver a proprietary mode of stimulation therapy called burst stimulation. The SUNBURST™ (Success Using Neuromodulation with BURST) study will evaluate whether burst stimulation can be more effective in managing chronic pain than traditional tonic stimulation.

Spinal cord stimulation is a proven therapy that has been used to manage chronic pain for more than 40 years. The procedure involves the implant of a small Neurostimulation device that powers thin wires placed along the spinal cord. The device emits low levels of electrical energy to interrupt or mask the transmission of pain signals to the brain. Patients with a traditional SCS system feel the mild pulses of energy as a tingling sensation called paresthesia. Early research indicates that burst stimulation may be able to deliver SCS therapy with little-to-no paresthesia and may be more effective than tonic stimulation, especially in managing complex back pain.

“Severe chronic pain has a debilitating effect on patients’ lives,” said Dr. Timothy Deer, an interventional pain physician, and president and chief executive officer of the Center for Pain Relief in Charleston, W. Va. “Burst stimulation may provide us with a comprehensive approach to managing patients whose pain is not adequately controlled with tonic spinal cord stimulation alone, or for those who lose therapeutic benefit over time. Importantly, we hope to demonstrate that burst stimulation produces paresthesia-free pain relief which may make it ideal for those who can’t tolerate traditional stimulation.”

The SUNBURST study is a randomized, prospective, multicenter, clinical study designed to demonstrate the safety and efficacy of the Prodigy Neurostimulation system using tonic and burst stimulation therapy to manage patients with chronic intractable pain. A maximum of 442 patients will be enrolled at up to 50 sites in the U.S.

“The Prodigy spinal cord stimulation system with burst stimulation technology represents an important advancement in Neurostimulation therapy,” said Dr. Mark D. Carlson, chief medical officer and vice president of global clinical affairs for St. Jude Medical. “We are excited to be leading the effort through the SUNBURST study to bring this novel stimulation mode to market, offering physicians a new alternative to manage patients suffering from severe chronic pain.”

The Prodigy neurostimulator is a new investigational device with an expected 10-year battery life that requires recharging approximately once a week. The neurostimulator is designed to deliver both tonic and burst stimulation which may be able to address pain not fully managed by tonic stimulation alone.

The SUNBURST study is being conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). The Prodigy neurostimulator is not approved for use in the U.S.

For media attending the North American Neuromodulation Society (NANS) annual meeting Dec. 5-8 in Las Vegas please visit our booth in the exhibit hall.

About Chronic Pain and SCS

Chronic pain is a largely under-treated and misunderstood disease that affects millions of people worldwide. According to The Institute of Medicine (IOM) of the National Academies, chronic pain affects 100 million people in the U.S., and costs the nation up to $635 billion annually in medical treatment and lost productivity. Neurostimulation studies have shown that SCS systems can often reduce pain symptoms by 50 percent or more. By providing significant pain relief, SCS therapy enables many patients to increase their activity levels and improve their overall quality of life.

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 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 December 29, 2012 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 28, 2013. 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

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