St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the CE Mark approval and European launch of its Prodigy ™ Chronic Pain System with Burst Technology. As the first and only implantable neuromodulation system that delivers burst stimulation, the Prodigy system is designed to reduce pain, improve patient satisfaction and allow reduced paresthesia (a tingling sensation associated with stimulation). The new device offers patients traditional tonic spinal cord stimulation (SCS) in addition to Burst Technology for improved stimulation options. “Burst Technology expands treatment options for patients suffering from chronic pain and provides significant relief so they can reclaim their quality of life,” said Dr. Dirk De Ridder, Neurological Professor of Neurosurgery, from the University of Otago in Dunedin, New Zealand. “Prodigy’s pioneering stimulation mode allows me to tune therapy to my patient’s unique pain condition. Burst holds promise to fill the void where alternative stimulation modes fail to control patients’ pain or for those who lose therapeutic benefit over time.” SCS (also known as neurostimulation) therapy uses an implanted device, similar to a cardiac pacemaker, and thin wires with electrodes to deliver low levels of electrical energy to nerve fibers. These electrical pulses mask or interrupt pain signals as they travel to the brain, reducing painful sensations. Traditional stimulation uses equally spaced electrical pulses to replace pain with a tingling sensation called paresthesia. For some patients, the stimulation sensation can fluctuate and paresthesia may become uncomfortable. For others, traditional stimulation does not effectively relieve their pain. St. Jude Medical’s new Burst Technology offers intermittent “bursts” of stimulation designed to provide an alternative therapy method for chronic conditions such as back pain. In addition, burst stimulation has been demonstrated to minimize paresthesia in some patients which can often fluctuate with posture and body position changes. Early evidence suggests that by enabling the delivery of both modes of stimulation, clinicians can more effectively adjust therapy to address the patient’s unique pain condition.
SUNBURST™ (Success Using Neuromodulation with BURST) is evaluating whether burst stimulation can be more effective in managing chronic pain than traditional tonic stimulation. The Prodigy neurostimulator is not approved for use in the U.S. Tweet This: #StJudeMedical gains #CEMark for Prodigy System w/ Burst Technology for patients with #chronicpain. www.sjm.com/corporate/media-room/media-kits/new-products/prodigy About Spinal Cord Stimulation SCS is a proven therapy that has been used for more than 40 years to help manage chronic pain and improve patients’ quality of life. Neurostimulators are similar in function and appearance to cardiac pacemakers, delivering mild electrical pulses to the spinal cord, which interrupt or mask the pain signals’ transmission to the brain. St. Jude Medical neurostimulation devices have been implanted in patients in more than 40 countries around the world. Patients can obtain more information about neurostimulation pain therapies at poweroveryourpain.com. 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 December 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.