St. Jude Medical Receives CE Mark Approval for Full Body MR Conditional Labeling for the Proclaim Elite Spinal Cord Stimulation System
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE mark approval for full-body magnetic resonance (MR) conditional labeling of the Proclaim™ Elite Spinal Cord Stimulation (SCS) System. With the latest approval, patients who receive the Proclaim Elite SCS System can now undergo full-body magnetic resonance imaging (MRI) diagnostic scans within approved parameters. The full-body MR conditional labeling is the second upgrade available to patients outside the United States implanted with the Proclaim Elite System, following a 2015 approval for MR Conditional labeling for head and extremity MRI scans.
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20161208005343/en/
Proclaim™ Elite Spinal Cord Stimulation System (Photo: Business Wire)
With the latest approval, patients living with chronic pain who have been implanted with the Proclaim Elite SCS System may now undergo full-body MRI diagnostic scans within approved parameters while retaining access to the treatments they need, such as the St. Jude Medical BurstDR™ stimulation.
“Providing patients with a multitude of therapy options in one device has positively impacted the way we treat chronic pain patients today,” said Dirk Rasche, M.D., functional neurosurgeon, University Hospital of Schleswig-Holstein, Campus Lübeck, Germany. “Patients now do not only have access to both traditional SCS and BurstDR stimulation, they can also safely undergo MRI scans, a significant improvement for future neuromodulation therapy and diagnostic options.”
The Proclaim Elite SCS System offers patients a combination of the convenience of a device that doesn’t require recharging while offering access to St. Jude Medical BurstDR stimulation technology. BurstDR stimulation is a physician-designed form of SCS clinically proven to provide patients superior pain relief (as compared to tonic stimulation) by reducing their physical pain and addressing their emotional response to pain as measured by visual analogue scale (VAS) scoring. Unlike other stimulation designs, St. Jude Medical BurstDR stimulation works differently, utilizing intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns.
St. Jude Medical was the first company to provide patients suffering from chronic pain a single device featuring upgradeable and recharge-free therapy solutions. The company designed the Proclaim System with patient-centric solutions in mind. In addition, the Proclaim Elite SCS System’s Bluetooth® wireless technology allows clinicians to program and adjust their patient’s SCS therapy with an Apple™ iPad mini™ mobile digital device.
“Historically, the need for future MRI scans could act as a barrier to patients who may benefit from SCS therapy,” said Dr. Allen W. Burton, medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “Our new labeling for the Proclaim Elite SCS System ensures that patients can receive the treatment they need, while having peace of mind knowing their SCS system can be safely scanned with the diagnostic imaging they require.”
Nearly 95 million Europeans suffer from chronic pain, and the condition costs European health care systems a combined total of 300 billion Euro annually due to associated medical costs, lost work days and social security and welfare payments. SCS therapy can offer many patients meaningful pain relief and improvements in quality of life, yet for some patients the need for future MRI scans can act as a barrier to SCS therapy.
Full body MR-conditional labeling for the Proclaim Elite System was also recently approved by the Food and Drug Administration in the United States.
Note: Apple and iPad Mini are trademarks of Apple, Inc. Bluetooth is a trademark of Bluetooth SIG, Inc.
About St. Jude Medical
St. Jude Medical is a leading global medical device manufacturer and is 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 employs approximately 18,000 people worldwide and has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management and cardiovascular. 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, 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 October 1, 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.
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
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
Elliott Advisors (UK) Limited Statement on Telecom Italia23.3.2018 07:00 | Pressemelding
Given the momentum behind Elliott's campaign at Telecom Italia to improve both performance and governance, Elliott was not surprised to see yesterday's resignation of seven board members affiliated with Vivendi. Unable to advance any meritorious arguments, the Board has simply abandoned their posts to stall for time. Elliott regards this action as cynical and self-serving, in that it delays the ability of Telecom Italia shareholders to express their votes at the upcoming AGM. This is yet another example of minority shareholder rights at Telecom Italia being abrogated and the continued disregard of corporate governance best practice. Finally, Vivendi should note Elliott's forty-year track record of consistent value creation, and sustained, long-term commitments to expose poor governance and catalyse positive change; Elliott's investment history in Telecom Italia dates back to 1999, well before Vivendi became a shareholder in the Company. About Elliott Elliott Management Corporation mana
Smiths Detection Hold Baggage Scanner Meets Highest Security Standards in EU23.3.2018 07:00 | Pressemelding
The Smiths Detection HI-SCAN 10080 XCT has achieved ECAC approval as a Standard 3.1 explosives detection system for hold baggage – the highest, defined security standard in the EU. This significant advance was made possible by using a dual-view, dual-energy line scanner with high resolution 3D Computed Tomography (CT) to deliver exceptional data. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180323005050/en/ Smiths Detection HI-SCAN 10080 XCT (Graphic: Business Wire) This achievement gives airports currently upgrading to Standard 3 technology, the option to increase detection levels even further to 3.1; and any standard 3 systems already installed can be easily elevated to 3.1 via a software upgrade. The detection algorithms are interchangeable on a bag by bag basis depending on the destination and associated risk level. This offers additional flexibility and productivity. “With the capability to meet detection requirements
Sofinnova Partners Leads SafeHeal’s €6 Million Series a Financing Round23.3.2018 07:00 | Pressemelding
SafeHeal, an early-stage medtech company specialized in digestive surgery and focused on the development of the Colovac device, announces today that it has closed a €6 million Series A financing round led by Sofinnova Partners. Based in Paris, SafeHeal develops an innovative digestive anastomosis protection device, called Colovac, designed to reduce complications and obviate the need for ostomies for colectomy patients. This technology consists of a minimally invasive and fully reversible implant that remains in place until the body’s natural healing and tissue repair processes are complete, for approximately two weeks, after which it is removed. SafeHeal’s device has the potential to radically transform the market while significantly improve patients’ quality of life by enabling them to resume their normal life without having to bear an artificial anus and wear ostomy pouches for several months. About 270,000 colectomy patients receive an ostomy every year in Europe and the USA, repre
Ipsen Receives Positive CHMP Opinion for Cabometyx® (cabozantinib) for the First-Line Treatment of Adults with Intermediate- or Poor- Risk Advanced Renal Cell Carcinoma23.3.2018 06:00 | Pressemelding
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA) provided a positive opinion for Cabometyx® (cabozantinib) 20, 40, 60 mg for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma (aRCC).The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Alexandre Lebeaut, Executive Vice President, R&D and Chief Scientific Officer said: “Today’s positive opinion from the CHMP is important news for patients with previously untreated advanced renal cell carcinoma, who can shortly benefit from Cabometyx ® as a new first-line treatment option. Following the evidence of its clinical value after a prior VEGF-targeted treatment, we are pleased to be able to expand the benefit of Cabometyx ® for treatment-naïve patients wit
Swiss Wearable Brand MyKronoz Breaks Worldwide Records with its Hybrid Smartwatch ZeTime, on the Sidelines of a Challenging Baselworld 201822.3.2018 16:32 | Pressemelding
On the sidelines of a downsized Baselworld 2018, MyKronoz, the premier watchmaking brand of the smart generation today announces record-breaking crowdfunding results of its hybrid smartwatch ZeTime, with more than $8,000,000 raised in less than a year. The international success of its unique and groundbreaking flagship wearable is followed by the release of a new digital video campaign “I’m a watch; I’m a smartwatch”. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180322005963/en/ MyKronoz ZeTime Petite & Regular top $8M in crowdfunding (Photo: Business Wire) After a historic 35-days Kickstarter campaign launched in March 2017, ZeTime has pursued, since then, its crowdfunding journey on a variety of international and local platforms: Indiegogo, Makuake in Japan, Zec Zec in Taïwan, Wadiz in Korea and on the leading chinese e-commerce website JD.com. Further to this online momentum, MyKronoz has successfully shipped to over 10
Redwood Software Announces First Industry Robotic Licensing Model to Revolutionize Transparent Marketplace Pricing22.3.2018 14:59 | Pressemelding
Redwood Software, the pioneer behind ‘The Robotic Enterprise’, today announced the launch of a revolutionary new robotic licensing model, where customers only pay for the robotic services they consume within their business. Available now, this new licensing model allows customers to directly compare the costs of manual work against processes that are robotized. With the unique Robotic Service Charge, Redwood only charges for the delivery of a robotic service, equivalent to a unit of work that can done by a person (send an email, download a report, reconcile two reports etc.). Redwood delivers a catalogue of 35,000 of these ready built robotic services that can be linked together by business users in a visual plug and play interface. End-to-end business processes can be modelled, robotized, tested and deployed without cost and risk. Only when the robotic service is consumed is a charge made, always replacing work that would otherwise be done manually. Within the Robotic Service Charge,