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

11.12.2015 19:30 | Business Wire

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

IBC’s Big Screen to Explore the Future of Camera and Display Technologies and the Business Behind Cinema22.8.2017 16:58Pressemelding

IBC today announced the details of its Big Screen programme, taking place in a specially built auditorium designed to IBC’s specifications and featuring the very latest in cinema technology. With the latest Dolby Vision dramatic imaging and Dolby Atmos immersive audio sound installation, the four-day programme examines and demonstrates the hottest topics, themes, and insights surrounding the art, science, and business of cinema - from capture through to exhibition. As well as being the home of the Big Screen programme, the auditorium will screen in Dolby Vision and Dolby Atmos, Baby Driver, the acclaimed Edgar Wright feature from 2017. The programme for 2017, which has been shaped by a committee of global industry professionals, is an insightful examination of the future of cinema. From virtual reality in cinema to laser and camera assessments, visitors will get up to speed

Digi Communications N.V. Announces the Publishing of an Update to the Investigation by the Romanian National Anti-Corruption Directorate22.8.2017 16:38Pressemelding

In connection with the investigation triggered by the Romanian National Anti-Corruption Directorate (“DNA”), which we have previously disclosed to the market and to our investors in the initial public offering prospectus dated 26 April 2017, in the supplemental prospectus dated 8 May 2017 (together, the “Prospectus”), as well as in the subsequent public reports, we inform you that, based on the public release no 832/VIII/3 issued on 22 August 2017, the DNA sent to court under the judiciary control Mr. Ioan Bendei (Vice-president of the Board of Directors of RCS & RDS S.A. – the Company’s subsidiary („RCS&RDS”)) in connection with the offences of bribery and accessory to money laundering, as well as RCS&RDS in connection with the offences of bribery and money laundering, INTEGRASOFT S.R.L. (one of RCS&RDS’s subsidiaries in Romania) in connection with the offence of accessory to mon

SailPoint Named a Leader in Cloud-based Identity Governance22.8.2017 14:00Pressemelding

SailPoint, the leader in enterprise identity management, was recently named the overall market leader in KuppingerCole’s 2017 “Leadership Compass: Identity as a Service: Cloud-based Provisioning, Access Governance and Federation.” In addition to being named a leader in every category of the report, SailPoint received superior rankings in four of the five evaluation criteria: security, functionality, interoperability and usability. KuppingerCole is an international and independent analyst organization with a strong focus on Information Security and Identity and Access Management. KuppingerCole’s Leadership Compass reports provide an in-depth analysis of the main players in the market, defining each as a follower, challenger or leader. The Leadership Compass Report for IDaaS evaluates leaders in innovation, product features, and market reach for identity-as-a-service offerings tar

Meggitt Training Systems to Exhibit at DSEI 201722.8.2017 14:00Pressemelding

Meggitt Training Systems, the leading provider of integrated live-fire and virtual weapons training products and services for armed forces and law enforcement, will participate at Defence and Security Equipment International (DSEI) through the Georgia Department of Economic Development. The military and security industry event will be held September 12-15, 2017 at ExCeL in London, England. “Today’s threats necessitate maximum realism, despite stretched budgets, and that’s what Meggitt provides to government and commercial customers globally,” said Mark Mears, managing director at Meggitt Training Systems, Ltd. “Although proudly based in Georgia, Meggitt Training Systems is part of Meggitt PLC, a UK-headquartered corporation. As such, we particularly look forward to engaging with current and prospective customers at DSEI, the UK’s largest defense and security trade show.” On

Camelbay Real Estate Management NL B.V. Selects Yardi Voyager22.8.2017 13:58Pressemelding

Camelbay Real Estate Management NL B.V. will utilise Yardi Voyager® 7S, a browser-agnostic, fully mobile Software-as-a-Service platform, as its accounting and property management platform. Camelbay will use Yardi Voyager to streamline its property management, leasing and accounting processes for its Dutch real estate portfolio, which is predominantly comprised of commercial office assets. “The automation, transparency and fully integrated accounting and property management that Voyager provides will help us manage our daily financial and operational activities more efficiently and enhance our competitive position within the Dutch office market,” said Alon Levy, Director of Camelbay Real Estate Management NL B.V. “We are very pleased to welcome Camelbay as our latest client in the Netherlands,” said Neal Gemassmer, Vice President of International for Yardi.

Laser Design CyberGage®360, Automated 3D Scanning & Inspection System Adopted by Proto Labs in their State-of-the-Art Metrology Lab22.8.2017 13:44Pressemelding

Laser Design, Inc., a subsidiary of CyberOptics (NASDAQ:CYBE), and premier provider of ultra-precise 3D scanning systems and services, announces the adoption of the CyberGage360 3D Scanning and Inspection system by Proto Labs, the world’s fastest digital manufacturing source for custom prototypes and low-volume production parts providing unprecedented speed-to-market value for designers and engineers. “At Proto Labs, we strive to challenge the traditional rules of manufacturing in order to deliver custom manufactured components at unprecedented speeds,” said Dylan Lundberg, Senior Manufacturing Engineer of Protoworks, Proto Labs’ R&D lab. “Everything we do revolves around reducing our customers’ time to market and we do that by digitalizing the entire manufacturing process. From our front-end services to our proprietary processes on the manufacturing floor, you will find thr

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

Besøk vårt presserom