St. Jude Medical Announces FDA Approval of BurstDR Stimulation, a New Superior Spinal Cord Stimulation Option for Patients Suffering from Chronic Pain

ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. approval of BurstDR™ stimulation, a physician-designed form of spinal cord stimulation (SCS) clinically proven to provide superior outcomes for patients with chronic pain over traditional SCS therapy. With FDA approval of BurstDR stimulation, which is exclusive to St. Jude Medical, the company aims to help patients find relief from their pain and suffering while also providing patients a better experience with their chronic pain therapy.

Chronic pain is a complex and challenging condition for physicians to manage, and a heavy burden for patients who find their lives profoundly limited by their pain. Many patients often move from treatment option to treatment option seeking pain relief, only to find a partial or incomplete response to therapy.

Fortunately, SCS therapy can transform quality of life for many people who are otherwise unable to find relief from chronic pain. BurstDR stimulation from St. Jude Medical has been clinically proven to improve upon traditional SCS by generating superior pain relief. With BurstDR stimulation, St. Jude Medical is also helping physicians address their patients’ physical and emotional responses to pain and reduce overall pain and suffering as measured by patients who reported their responses to therapy with BurstDR stimulation through visual analogue scale (VAS) scoring.

“As a physician, reducing the physical sensation of pain experienced by my patients is only part of my job; my ultimate goal is to help patients overcome both the physical pain and the suffering associated with their pain,” said Dr. Timothy R. Deer, president and chief executive officer of The Center for Pain Relief in Charleston, West Virginia. “Now, with BurstDR stimulation, St. Jude Medical has armed physicians with a new therapy option that can reduce patients’ pain and suffering, reduce paresthesia and help us offer our patients a more complete pain management option.”

St. Jude Medical’s proprietary BurstDR stimulation works differently from other stimulation designs, utilizing intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns. While other companies have tried to mimic burst patterns, BurstDR stimulation from St. Jude Medical is the only approved form of burst stimulation to have been evaluated in a large scale, multicenter randomized controlled clinical trial.

The St. Jude Medical BurstDR stimulation was introduced after nearly a decade of research and study in collaboration with Prof. Dirk De Ridder, who filed the therapy’s initial patents in 2004. BurstDR stimulation was evaluated within the SUNBURST study, a prospective, randomized multicenter study which confirmed BurstDR stimulation offered superior pain relief over traditional SCS and that the therapy was preferred by most patients over traditional SCS therapy. In addition, BurstDR stimulation from St. Jude Medical has been studied in a large number of international real world studies that have helped the company assess the benefits of the therapy in patients worldwide.

“I am very excited that patients across the United States will now have access to BurstDR stimulation, which has enjoyed strong success across other global markets,” said Prof. De Ridder, from the University of Otago in Dunedin, New Zealand. “When I developed BurstDR stimulation my goal was to introduce an entirely new therapy option, and one that was rooted in the natural way in which the human body responds to and combats the sensation of pain.”

With FDA approval of BurstDR stimulation, patients receiving new implants of the St. Jude Medical Proclaim™ Elite and Prodigy MRI™ spinal cord stimulation systems will have immediate access to the new therapy. Combined, the Proclaim Elite SCS System and BurstDR stimulation offers patients the advantages of the St. Jude Medical Invisible Therapy™ portfolio and an entirely recharge free option, allowing patients to focus on their lives instead of their pain. In addition, patients previously implanted with upgradeable Protégé™ and Proclaim SCS systems will soon be able to upgrade their systems to deliver BurstDR stimulation without additional surgery.

“Chronic pain is one of the most costly epidemic diseases facing health care systems worldwide, and one of the most challenging for physicians to manage due to the complexity of the condition and the differences in each patient’s clinical case,” said Allen W. Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “With FDA approval of BurstDR stimulation, we are empowering physicians with a new therapy option in their fight against widespread chronic pain, and our goal is to continue to improve patient outcomes and get more patients the pain relief they deserve.”

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 chronic pain therapy solutions and the only medical device manufacturer in the world to offer radiofrequency ablation (RFA) and spinal cord stimulation (SCS) therapy solutions including BurstDR stimulation and stimulation of the dorsal root ganglion (DRG) for the treatment of chronic pain.

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, reimbursement strategies, 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 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended July 2, 2016. The company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.