St. Jude Medical Announces European Launch of the World’s First and Only Upgradeable, Non-Rechargeable, Burst-Enabled MR-Conditional SCS System
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company and an international leader in chronic pain therapy development, today announced the European launch of the Proclaim™ Elite Spinal Cord Stimulation System, the first and only upgradeable and non-rechargeable spinal cord stimulation (SCS) system approved to deliver burst stimulation from St. Jude Medical. The approval also includes conditional magnetic resonance (MR) labeling for the Proclaim Elite SCS system, which will allow patients to safely undergo head and extremity MRI scans.
St. Jude Medical designed many elements of the Proclaim Elite SCS system based on physician and patient feedback to ensure patients could benefit from all aspects of the product. In particular, the non-rechargeable system incorporates a new level of convenience by removing the burden of patients needing to regularly recharge their SCS system. St. Jude Medical has further enhanced ease-of-use and familiarity for patients by leveraging Bluetooth® wireless technology and Apple™ mobile digital devices for the Proclaim Elite SCS system’s patient controller and clinician programmer to improve interaction with the device and allow for effective management of their chronic pain treatment.
In addition, by providing access to both traditional SCS and burst stimulation from St. Jude Medical in one SCS system, the device can improve patient outcomes and provide options for patients who either didn’t initially respond to traditional SCS therapy or those who might lose pain relief over time. The Proclaim Elite SCS system is also upgradeable, allowing easier access to future therapy and software advances as they’re approved in the future.
“We developed the Proclaim Elite SCS system to create a more patient-centric spinal cord stimulation therapy option,” said Allen Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “With the launch of this device we are transforming the standard of care by packaging a series of important benefits into a single SCS device. The Proclaim Elite SCS system offers patients a combination of advanced pain therapy options and the convenience of a device that doesn’t require recharging, while removing barriers for future therapy and diagnostic options.”
The novel upgradeable platform of the Proclaim Elite SCS system allows patients to access future SCS technology upgrades without surgical device replacement. Historically, most patients would need additional surgery to receive new product features and benefits.
“With the Proclaim system, we’re seeing a shift in the SCS treatment paradigm as we move to a device that’s capable of delivering effective therapy tailored to a patient’s pain condition but that requires no device recharging,” said Frank Huygen, M.D., Ph.D., an anesthesiologist and pain specialist from Erasmus MC Hospital in the Netherlands. “By combining burst stimulation and upgradeability in a non-rechargeable device, this innovative technology ensures physicians are more empowered to deliver therapy that can appropriately address our patients pain while keeping them on the forefront of therapy advancements as they are approved and securing access to MRI head and extremity scans if needed.”
According to the International Neuromodulation Society, nearly 95 million people in Europe suffer from chronic pain, a serious condition that can negatively impact a patient’s personal relationships, work productivity and quality of life. Traditional tonic SCS therapy has been proven to offer meaningful chronic pain relief for many patients, but some patients do not respond to tonic SCS therapy or can see a reduced benefit from the therapy over time.
The proprietary burst stimulation developed by St. Jude Medical works differently from other stimulation designs, utilizing intermittent “burst” pulses designed to mimic the body’s natural nerve firing patterns and provide a more physiologic therapy method for chronic pain conditions. St. Jude Medical is the only company approved to offer patients burst stimulation, which was introduced after nearly a decade of research and study in collaboration with Dirk De Ridder, M.D., Ph.D., who filed the therapy’s initial patents in 2005. St. Jude Medical will present the results of the SUNBURST U.S. IDE study evaluating burst stimulation during the upcoming 19th annual meeting of the North American Neuromodulation Society (NANS) in Las Vegas, Nevada. The SUNBURST study is designed to support approval of burst stimulation in the U.S.
In addition to improved pain relief, in most patients, burst stimulation has been demonstrated to significantly reduce or eliminate paresthesia, the tingling sensation commonly associated with traditional SCS. By offering both stimulation waveforms in both rechargeable and non-rechargeable devices, St. Jude Medical provides patients a range of therapeutic options.
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 innovative chronic pain therapeutic options and offers multiple solutions for patients to manage debilitating chronic pain, including spinal cord stimulation, spinal cord stimulation targeting the dorsal root ganglion (DRG) and radiofrequency ablation (RFA).
About Burst Stimulation
Burst stimulation developed by St. Jude Medical is a proprietary neurostimulation waveform that functions differently from cycling modes and programming currently available from other SCS systems. Burst stimulation delivers closely-spaced pulses of electrical energy to a patient’s spinal cord to manage chronic pain. St. Jude Medical has led rigorous development and ongoing clinical study of burst stimulation and is the only company approved to offer burst therapy. Burst stimulation may be an option for patients whose pain is not adequately controlled, or for those who lose therapeutic benefit over time with tonic SCS alone.
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 .
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.
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