|By Business Wire||
|April 4, 2014 08:01 AM EDT||
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the approval of its Protégé™ IPG from the U.S. Food and Drug Administration (FDA). Protégé is the first and only neurostimulation system that allows spinal cord stimulation (SCS) technology upgrades as they are approved to be made via software updates. Chronic pain sufferers implanted with this new device can access innovative therapies, stimulation modes, diagnostics or other features once approved through future software upgrades — without the need to surgically replace their medical device.
The Protege (TM) upgradeable neurostimulator from St. Jude Medical, Inc. (Photo: St. Jude Medical)
Chronic pain affects 100 million Americans, more than heart disease, cancer and diabetes combined. The debilitating disease is cause for 40 percent of work absences due to back pain, second only to the common cold (50 percent), and costs the nation more than $635 billion each year in medical treatment and lost productivity. SCS is a proven therapy that has been used to help manage chronic pain and improve patients’ quality of life.
“In the first 40 years of SCS we’ve seen advances in hardware but limited progress in software and programming. This new device evolves with promising therapies,” said Dr. Timothy Deer, an interventional pain physician, president and CEO of the Center for Pain Relief in Charleston, W. Va., and president-elect of the International Neuromodulation Society, who was the first physician to implant a Protégé system. “With its upgradeability, SCS patients can readily access newly approved stimulation methods, allowing the latest technology to be synced with their medical device. This will reduce additional surgeries and lower the cost of care.”
Until now, one of the greatest challenges with neurostimulation has been giving patients access to the latest technologies without surgically replacing their medical device. Protégé changes the standard for SCS, allowing patients to access future innovations and therapies once approved without the cost and risks associated with surgical replacement.
Protégé is the world’s smallest neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery. It has an unmatched seven-year warranty and offers industry-leading 10-year projected battery life. It also has open-ended device longevity without an automatic shutoff. Protégé is built on a solid platform of success: Eighty-eight percent of patients report satisfaction at two years post-implant with a St. Jude Medical neurostimulator, saying their quality of life has been greatly improved.1
Spinal cord stimulation is an important therapy option for patients who have not been able to alleviate their chronic pain through traditional methods. Similar in function and appearance to a cardiac pacemaker, the Protégé neurostimulator delivers mild electrical pulses to the spinal cord, which interrupt or mask the pain signals' transmission to the brain.
“Spinal cord stimulation therapy can transform the quality of life for patients who are otherwise unable to find relief from their chronic pain,” said Eric S. Fain, M.D., group president of St. Jude Medical. “Protégé allows patients the opportunity to benefit from future therapies and features even after they receive their implanted system. This draws upon St. Jude Medical’s promise to the quality and durability of its products and our commitment to continuously innovating in the neuromodulation space.”
Spinal Cord Stimulation Research
The Protégé neurostimulator and Prodigy™ Chronic Pain System with Burst Technology, which recently earned European approval, represent St. Jude Medical’s devotion to advancing new therapies in neuromodulation and providing options for chronic pain sufferers. Additionally, two clinical trials sponsored by St. Jude Medical that started in December 2013 are investigating alternative stimulation methods in spinal cord stimulation.
Through an Investigational Device Exemption (IDE) from the FDA, St. Jude Medical is evaluating whether a new waveform called burst stimulation can be more effective in managing chronic pain than traditional tonic stimulation. The purpose of the study, dubbed SUNBURST™ (Success Using Neuromodulation with BURST), is to evaluate the safety and efficacy of the Prodigy neurostimulator for the treatment of chronic intractable pain of the trunk and/or limbs. Prodigy is not approved for use in the U.S.
The SENSE™ Subcutaneous and Epidural Neuromodulation System Evaluation study is designed to evaluate the combination of peripheral nerve field stimulation (PNfS) and SCS to determine whether the two therapies together offer more effective management of chronic low back and leg pain than SCS alone.
About Chronic Pain
Chronic pain affects approximately 1.5 billion people worldwide. In the U.S., estimated costs include 515 million workdays lost and 40 million doctor visits annually. Today, patients around the world benefit from transformational pain management technologies from St. Jude Medical that enable them to return to work and live fuller, more satisfying lives. Patients can obtain more information about neurostimulation pain therapies at poweroveryourpain.com.
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 December 28, 2013. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
1. Mironer, E.; Berstein, C.A.; Masone, R.; Garcia. E.; Amayem, A.; Johans, T.; Ghodsi, A.; Leung, A.; Rosenberg, J.; Golovac, S. (INS 2011) “A Prospective Clinical Evaluation of a Rechargeable Implantable Pulse Generator (IPG): Final analysis of the Sustainability of Spinal Cord Stimulation Therapy for Chronic Lower Back Pain
SYS-CON Events announced today that IndependenceIT, a leading software provider of simplified IT management solutions for workspaces, applications and desktops-as-a-service, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. IndependenceIT's Cloud Workspace® Suite combines application, end-user and infrastructure management into a seamless, easy-to-manage platform, with a unified management interface an...
Apr. 25, 2015 03:15 AM EDT Reads: 2,823
GENBAND has announced that SageNet is leveraging the Nuvia platform to deliver Unified Communications as a Service (UCaaS) to its large base of retail and enterprise customers. Nuvia’s cloud-based solution provides SageNet’s customers with a full suite of business communications and collaboration tools. Two large national SageNet retail customers have recently signed up to deploy the Nuvia platform and the company will continue to sell the service to new and existing customers. Nuvia’s capabili...
Apr. 25, 2015 03:15 AM EDT Reads: 1,869
SOASTA, the leader in performance analytics, today reported record growth of the CloudTest community, exceeding 30,000 registered users of the CloudTest platform in Q1 2015. SOASTA also announced widespread adoption of its Web and mobile testing solutions, with more than 1,600 customers completing more than 285,000 tests using CloudTest during the quarter. This rapid growth shows that DevOps-driven digital businesses are embracing a more continuous approach to testing, and CloudTest is meeting t...
Apr. 25, 2015 03:00 AM EDT Reads: 1,537
SYS-CON Events announced today that that Innodisk, the service-driven provider of industrial embedded flash and DRAM storage products and technologies, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Innodisk is a service-driven provider of industrial embedded flash and DRAM storage products and technologies. With satisfied customers across the embedded, aerospace and defense, cloud storage markets an...
Apr. 25, 2015 03:00 AM EDT Reads: 2,892
SYS-CON Events announced today that WSM International (WSM), the world’s leading cloud and server migration services provider, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. WSM is a solutions integrator with a core focus on cloud and server migration, transformation and DevOps services.
Apr. 25, 2015 02:45 AM EDT Reads: 1,980
VoxImplant has announced full WebRTC support in the newest versions of its Android SDK and iOS SDK. The updated SDKs, which enable audio and video calls on mobile devices, are now compatible with the WebRTC standard to allow any mobile app to communicate with WebRTC-enabled browsers, including Google Chrome, Mozilla Firefox, Opera, and, when available, Microsoft Spartan. The WebRTC-updated SDKs represent VoxImplant's continued leadership in simplifying the development of real-time communication...
Apr. 25, 2015 02:45 AM EDT Reads: 2,190
SYS-CON Events announced today that Site24x7, the cloud infrastructure monitoring service, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Site24x7 is a cloud infrastructure monitoring service that helps monitor the uptime and performance of websites, online applications, servers, mobile websites and custom APIs. The monitoring is done from 50+ locations across the world and from various wireless carr...
Apr. 25, 2015 02:30 AM EDT Reads: 2,055
Today, IT is not just a cost center. IT is an enabler and driver of business. With the emergence of the hybrid cloud paradigm, IT now has increasingly more capabilities to create new strategic opportunities for a business. Hybrid cloud allows an organization to utilize multi-tenant public clouds, dedicated private clouds, bare metal hosting, and the associated support and services for the right use cases through an on-demand, XaaS model. This model of IT creates tremendous opportunities for busi...
Apr. 25, 2015 02:30 AM EDT Reads: 4,021
SYS-CON Events announced today that Intelligent Systems Services will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Established in 1994, Intelligent Systems Services Inc. is located near Washington, DC, with representatives and partners nationwide. ISS’s well-established track record is based on the continuous pursuit of excellence in designing, implementing and supporting nationwide clients’ mission-cri...
Apr. 25, 2015 02:15 AM EDT Reads: 2,775
SYS-CON Events announced today that B2Cloud, a provider of enterprise resource planning software, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. B2cloud develops the software you need. They have the ideal tools to help you work with your clients. B2Cloud’s main solutions include AGIS – ERP, CLOHC, AGIS – Invoice, and IZUM
Apr. 25, 2015 02:00 AM EDT Reads: 3,562
Sonus Networks introduced the Sonus WebRTC Services Solution, a virtualized Web Real-Time Communications (WebRTC) offer, purpose-built for the Cloud. The WebRTC Services Solution provides signaling from WebRTC-to-WebRTC applications and interworking from WebRTC-to-Session Initiation Protocol (SIP), delivering advanced real-time communications capabilities on mobile applications and on websites, which are accessible via a browser.
Apr. 25, 2015 02:00 AM EDT Reads: 1,965
SYS-CON Events announced today that Tufin, the market-leading provider of Security Policy Orchestration Solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. As the market leader of Security Policy Orchestration, Tufin automates and accelerates network configuration changes while maintaining security and compliance. Tufin's award-winning Orchestration Suite™ gives IT organizations the power and a...
Apr. 25, 2015 01:45 AM EDT Reads: 3,583
SYS-CON Events announced today that Cloudian, Inc., the leading provider of hybrid cloud storage solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Cloudian, Inc., is a Foster City, California - based software company specializing in cloud storage software. The main product is Cloudian, an Amazon S3-compliant cloud object storage platform, the bedrock of cloud computing systems, that enables c...
Apr. 25, 2015 01:00 AM EDT Reads: 2,726
“With easy-to-use SDKs for Atmel’s platforms, IoT developers can now reap the benefits of realtime communication, and bypass the security pitfalls and configuration complexities that put IoT deployments at risk,” said Todd Greene, founder & CEO of PubNub. PubNub will team with Atmel at CES 2015 to launch full SDK support for Atmel’s MCU, MPU, and Wireless SoC platforms. Atmel developers now have access to PubNub’s secure Publish/Subscribe messaging with guaranteed ¼ second latencies across PubN...
Apr. 25, 2015 01:00 AM EDT Reads: 3,844
SYS-CON Events announced today that Gridstore™, the leader in hyper-converged infrastructure purpose-built to optimize Microsoft workloads, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Gridstore™ is the leader in hyper-converged infrastructure purpose-built for Microsoft workloads and designed to accelerate applications in virtualized environments. Gridstore’s hyper-converged infrastructure is the ...
Apr. 25, 2015 12:45 AM EDT Reads: 4,636