Business Wire

New Data Demonstrates Burst Stimulation from St. Jude Medical Provides Superior Pain Relief over Traditional Tonic Spinal Cord Stimulation for the Treatment of Chronic Pain

Del

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the SUNBURST study has demonstrated that Burst stimulation from St. Jude Medical is superior to traditional tonic spinal cord stimulation (SCS) in relieving chronic pain. The SUNBURST study also found patients preferred Burst stimulation to traditional SCS and that a vast majority of patients experienced a reduction in paresthesia (a tingling sensation common during traditional SCS), or were paresthesia free when receiving Burst stimulation.

The results of the SUNBURST study, a prospective, randomized multicenter study designed to support U.S. approval of St. Jude Medical’s Burst stimulation, were presented today during a plenary session at the 19th annual meeting of the North American Neuromodulation Society (NANS) in Las Vegas, Nevada.

“We are excited to report the positive results of the SUNBURST study, which shows Burst stimulation can provide patients additional options to effectively manage their chronic pain,” said Timothy R. Deer, M.D., president and chief executive officer of The Center for Pain Relief in Charleston, West Virginia, and Chairman of the SUNBURST study. “Many U.S. pain physicians and their patients have long been hopeful for new options to treat chronic pain, and now the SUNBURST trial has clinically demonstrated that Burst stimulation is a meaningful therapy to support improved management of chronic pain while reducing, and in the majority of patients eliminating, paresthesia.”

The SUNBURST study was designed to assess the effects of Burst stimulation from St. Jude Medical, and enrolled 100 patients from 20 centers across the United States randomized to either receive tonic stimulation prior to Burst stimulation, or to receive Burst stimulation prior to tonic stimulation. After six months, an analysis of the first 85 patients to complete their 24 week visit showed Burst stimulation delivered:

  • Superior pain relief: The study met its primary endpoint of non-inferiority and achieved statistical significance for its pre-specified secondary endpoint of superiority demonstrating patients receiving St. Jude Medical’s Burst stimulation achieved superior pain relief and greater treatment success when compared to patients receiving traditional SCS.
  • Patient preference: A statistically significant majority of patients (69.4 percent) in the SUNBURST study preferred Burst stimulation to tonic SCS for the treatment of chronic pain.
  • Reduced paresthesia: The vast majority (91 percent) of patients reported a decrease in paresthesia during treatment with Burst stimulation relative to tonic SCS. In addition, 65 percent of SUNBURST patients were paresthesia free while using Burst stimulation from St. Jude Medical.

“St. Jude Medical is committed to developing solutions that can reduce the effect of complex epidemic diseases while improving patient care, and providing new treatment options for patients suffering from chronic pain is central to that goal,” said Allen Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “The results of the SUNBURST study have provided strong confirmation that our Burst stimulation therapy yields direct benefits for patients while offering superior pain relief and improved quality of life.”

According to the National Institutes of Health (NIH), chronic pain is typically defined as pain lasting longer than 12 weeks. The condition, which affects approximately 1.5 billion people worldwide, can take a physical and emotional toll on patients, many of whom try many different types of treatment options on their path to finding pain relief. Traditional tonic SCS has been proven to offer meaningful chronic pain relief for many patients, but between 20 to 30 percent of patients do not respond to tonic SCS therapy while some patients may 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 outside the United States Burst stimulation, which was introduced after a 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 2004. The results of the SUNBURST study are being used to support St. Jude Medical’s application for FDA approval of Burst therapy feature in the Prodigy and Protégé rechargeable SCS devices, as well the Proclaim non-rechargeable system.

St. Jude Medical will be hosting an investor event at the NANS Conference Friday, December 11th starting at 3:00pm PST. The event will include a presentation highlighting St. Jude Medical’s Neuromodulation portfolio and clinical data presented at NANS followed by a Q&A period. A live webcast of the event will also be available via the Investor Relations section of the St. Jude Medical website (http://investors.sjm.com/).

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 Burst 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, 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.

Contact information

St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
jweigelt@sjm.com
or
Justin Paquette, 651-756-6293
Public Relations
jpaquette@sjm.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Edgewater Networks Announces Event Sponsorship of BroadSoft Connections 201720.10.2017 21:00Pressemelding

Edgewater Networks, Inc., the industry leader in Network Edge Orchestration, announced today that it is an event sponsor of the BroadSoft Connections 2017 user conference, which takes place October 22-25 at the JW Marriott Phoenix Desert Ridge Resort & Spa in Phoenix, AZ. During the event, Edgewater Networks will feature demonstrations of the latest end-to-end network interoperability capabilities, including Zero Touch Provisioning, UC Analytics from the core to the endpoint, SD-WAN optimized for BroadSoft, and much more. Continuing a long-standing partnership with BroadSoft, Edgewater Networks has completed another level of BroadCloud certification, this time for local survivability which is critical for business continuity for SMB and Enterprise customers. BroadSoft’s PacketSmart is available on all EdgeMarc Intelligent Edges. All elements of the Network Edge Orchestration are

More than 70 Companies to Showcase Top Tech at CES Unveiled Paris20.10.2017 15:08Pressemelding

The Consumer Technology Association (CTA) today announced that more than 70 exhibitors will showcase their latest innovations at the now sold-out fifth annual CES Unveiled Paris The event will focus on the Internet of Things (IoT), connectivity and smart cities, and draw more than 600 attendees. CES Unveiled Paris will run from 2-7:30 PM on Tuesday, October 24, 2017 at the Palais Brongniart. Regional technology companies, top-tier media outlets, buyers and key industry influencers will come together at CES Unveiled Paris to get a direct look at the latest industry developments. The day kicks off with a CES news conference and CTA market trends presentation. Conference programming is followed by a tabletop exhibition & networking reception. Curated exhibitors will be there to showcase top tech from robotics and audio to smart home and augmented and virtual reality. Notable

Westinghouse Receives Regulatory Approval for Analysis Methodologies20.10.2017 12:15Pressemelding

Westinghouse Electric Company today announced that it has received approval from the U.S. Nuclear Regulatory Commission (NRC) for two new important analysis methodologies that will be used to upgrade Westinghouse- and Combustion Engineering-based nuclear steam supply system (NSSS) safety analyses. The approvals granted are for the new FULL SPECTRUMTM Loss of Coolant Accident (FSLOCATM) methodology and the Performance Analysis and Design Model software code update, PAD5. FSLOCA is capable of improved modeling of the transient response in a pressurized water reactor to the full spectrum of LOCA break sizes that could occur, and PAD5 is the next generation of the Westinghouse fuel rod design performance code. “These codes were developed to work in concert with each other to maximize analytical margin for nuclear utilities,” said Michele DeWitt, senior vice preside

Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread®20.10.2017 12:03Pressemelding

Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection, adding to the body of evidence supporting Gilead’s viral hepatitis therapies in diverse patient populations. These and other data from more than 25 abstracts will be presented this week at The Liver Meeting® 2017, which begins today in Washington, D.C. Positive results from studies of Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal impairment, Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) in HCV-infected liver transplant recipients and Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) in NS5A-inhibitor experienced HCV-infected patients will be presented during poster sessions on October 21 and October 22. In addition, updated results f

SP3H Announces That It Has Obtained a €1.2 Million European Union Grant for Its Intelligent and Clean Vehicle (VIP) Project20.10.2017 10:47Pressemelding

SP3H is proud to announce joining the very select circle of the 10 French winners of the H2020 SME Instrument Phase 2 program since 2014. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171020005325/en/ Last summer VIP received the very prestigious SME instrument phase 2 H2020 label in the "transport & smart cities mobility" category. With an overall budget of € 1.7 million, VIP is subsidized by the European Union at a rate of 70% or €1.2 million. The framework contract was officially signed early October. VIP is the pre-industrialization program for Fuelbox sensors, the world's first miniaturized scanner capable of analyzing the quality of fuels on board vehicles. The heart of the program remains closely linked to the reduction of CO2 and pollutant emissions from vehicle

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom