Click here to close now.

SYS-CON MEDIA Authors: Elizabeth White, Pat Romanski, Yeshim Deniz, Liz McMillan, Roger Strukhoff

News Feed Item

World's First and Only Upgradeable Spinal Cord Stimulation System Receives FDA Approval

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)

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.

Tweet This: #StJudeMedical gets #FDA approval for upgradeable neurostimulator, Protégé, to treat #chronicpain via @SJM_Media

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 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

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo in Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading in...
MeriTalk, a public-private partnership focused on improving the outcomes of government IT, today announced the results of its new report, "The Agile Advantage: Can DevOps Move Cloud to the Fast Lane?" The study, underwritten by Accenture Federal Services, reveals that approximately two-thirds of Feds say DevOps will help agencies shift into the cloud fast lane - improving IT collaboration and migration speed. But help is needed, with 66 percent saying that their agency needs to move IT services ...
The true value of the Internet of Things (IoT) lies not just in the data, but through the services that protect the data, perform the analysis and present findings in a usable way. With many IoT elements rooted in traditional IT components, Big Data and IoT isn’t just a play for enterprise. In fact, the IoT presents SMBs with the prospect of launching entirely new activities and exploring innovative areas. CompTIA research identifies several areas where IoT is expected to have the greatest impac...
Wearable devices have come of age. The primary applications of wearables so far have been "the Quantified Self" or the tracking of one's fitness and health status. We propose the evolution of wearables into social and emotional communication devices. Our BE(tm) sensor uses light to visualize the skin conductance response. Our sensors are very inexpensive and can be massively distributed to audiences or groups of any size, in order to gauge reactions to performances, video, or any kind of present...
There is little doubt that Big Data solutions will have an increasing role in the Enterprise IT mainstream over time. 8th International Big Data Expo, co-located with 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - has announced its Call for Papers is open. As advanced data storage, access and analytics technologies aimed at handling high-volume and/or fast moving data all move center stage, aided by the cloud computing bo...
Move from reactive to proactive cloud management in a heterogeneous cloud infrastructure. In his session at 16th Cloud Expo, Manoj Khabe, Innovative Solution-Focused Transformation Leader at Vicom Computer Services, Inc., will show how to replace a help desk-centric approach with an ITIL-based service model and service-centric CMDB that’s tightly integrated with an event and incident management platform. Learn how to expand the scope of operations management to service management. He will al...
Every day we read jaw-dropping stats on the explosion of data. We allocate significant resources to harness and better understand it. We build businesses around it. But we’ve only just begun. For big payoffs in Big Data, CIOs are turning to cognitive computing. Cognitive computing’s ability to securely extract insights, understand natural language, and get smarter each time it’s used is the next, logical step for Big Data.
The 4th International Internet of @ThingsExpo, co-located with the 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - announces that its Call for Papers is open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Enterprises are fast realizing the importance of integrating SaaS/Cloud applications, API and on-premises data and processes, to unleash hidden value. This webinar explores how managers can use a Microservice-centric approach to aggressively tackle the unexpected new integration challenges posed by proliferation of cloud, mobile, social and big data projects. Industry analyst and SOA expert Jason Bloomberg will strip away the hype from microservices, and clearly identify their advantages and d...
We are reaching the end of the beginning with WebRTC, and real systems using this technology have begun to appear. One challenge that faces every WebRTC deployment (in some form or another) is identity management. For example, if you have an existing service – possibly built on a variety of different PaaS/SaaS offerings – and you want to add real-time communications you are faced with a challenge relating to user management, authentication, authorization, and validation. Service providers will w...
DevOps Summit, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developmen...
The 5th International DevOps Summit, co-located with 17th International Cloud Expo – being held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the...
Over the years, a variety of methodologies have emerged in order to overcome the challenges related to project constraints. The successful use of each methodology seems highly context-dependent. However, communication seems to be the common denominator of the many challenges that project management methodologies intend to resolve. In this respect, Information and Communication Technologies (ICTs) can be viewed as powerful tools for managing projects. Few research papers have focused on the way...
As the world moves from DevOps to NoOps, application deployment to the cloud ought to become a lot simpler. However, applications have been architected with a much tighter coupling than it needs to be which makes deployment in different environments and migration between them harder. The microservices architecture, which is the basis of many new age distributed systems such as OpenStack, Netflix and so on is at the heart of CloudFoundry – a complete developer-oriented Platform as a Service (PaaS...
In high-production environments where release cycles are measured in hours or minutes — not days or weeks — there's little room for mistakes and no room for confusion. Everyone has to understand what's happening, in real time, and have the means to do whatever is necessary to keep applications up and running optimally. DevOps is a high-stakes world, but done well, it delivers the agility and performance to significantly impact business competitiveness.