ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced Health Canada approval and first implant in Canada of its Prodigy™ Chronic Pain System with Burst technology. The Prodigy system is the only implantable spinal cord stimulation (SCS) system approved to deliver St. Jude Medical’s proprietary Burst stimulation as well as traditional SCS to reduce pain, improve patient satisfaction and eliminate paresthesia, the tingling sensation commonly associated with traditional SCS, in some patients.
A 52-year-old man from Saskatoon, received the Prodigy neurostimulator on May 13 due to his experience with chronic pain for several years following a successful trial experience and was performed by Dr. Ivar Mendez, M.D., Ph.D, FRCSC, FACS, from Saskatoon Health Region’s Royal University Hospital in Saskatchewan, Canada.
Chronic pain affects one in five adults in Canada and more than 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, and is a serious public health issue that remains largely under-treated and misunderstood.
“Burst stimulation is a novel technology for SCS that has the potential to be effective in patients that do not respond well to traditional tonic stimulation. Studies have shown that with Burst stimulation patients can experience reduced paresthesia and pay less attention to their pain improving their overall experience with SCS therapy,” Mendez said, who is chairman of the Department of Surgery at the University of Saskatchewan and the Saskatoon Health Region’s Royal University Hospital. “SCS therapy can provide significant pain relief and thus enable many patients to increase their activity levels and improve their overall quality of life. In combination with conventional tonic stimulation, Burst stimulation represents a comprehensive approach to effective pain management and allows me to tailor the therapy to my patient’s unique situation.”
SCS therapy uses an implanted pulse generator 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 the sensation of pain. Traditional tonic stimulation uses equally spaced electrical pulses to replace pain with a tingling sensation called paresthesia. For some patients, the stimulation sensation can fluctuate with changes in body position and paresthesia may become uncomfortable.
St. Jude Medical’s Burst stimulation works differently, and offers intermittent “bursts” of stimulation, designed to mimic the human body’s natural design of neuron signaling and thus provide an alternative therapy method for chronic pain conditions. In addition, Burst stimulation has been shown to significantly reduce or eliminate paresthesia. The ability to support two modes of stimulation provides clinicians with the opportunity to more effectively adjust the therapy to a patient’s unique pain condition and may be especially helpful over time.
The Prodigy system features the longest-lasting battery life of all rechargeable SCS devices approved for use in Canada and, unlike some competitive devices, does not include a manufacturer-induced device shut-off. Additionally, its small size allows for a smaller incision, which gives physicians increased flexibility in selecting the implant location and is intended to make the site less visible and more comfortable for patients.
Through an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA), the St. Jude Medical study called 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.
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 April 4, 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.