St. Jude Medical Secures CE Mark Approval of MRI Compatibility for the Nanostim Leadless Pacemaker
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE Mark approval for magnetic resonance (MR) conditional labeling for 1.5 T scans for the company’s Nanostim™ leadless pacemaker. With the approval, throughout Europe both existing patients implanted with a Nanostim leadless pacemaker and new patients receiving a Nanostim leadless pacemaker in the future can safely undergo full-body MRI diagnostic scans.
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20160310005192/en/
The world's first commercially available retrievable leadless pacemaker, St. Jude Medical's Nanostim™ leadless pacemaker is now MRI Ready, allowing existing and future patients in Europe with this technology to undergo full body MRI scans. (Photo: Business Wire)
The latest approval builds upon the company's portfolio of MRI compatible products, and furthers patient access to the technological benefits of the Nanostim leadless pacemaker, the world’s first commercially available retrievable leadless pacemaker.
“Providing my patients access to a highly advanced pacemaker that can undergo an MRI scan is a notable step forward in treatment options,” said Dr. Johannes Sperzel, head of the electrophysiology department at the Kerckhoff Klinik in Bad Nauheim, Germany.
Dr. Tom Wong, cardiologist and electrophysiologist at Royal Brompton Hospital in London, adds, “It’s important that my patients in need of pacemakers also have the freedom to undergo MRI diagnostic scans for other conditions, if needed. This new labeling provides that flexibility and will be of great benefit to patients to ensure peace of mind for the future.”
More than 4 million people worldwide have an implanted pacemaker or other cardiac rhythm management device, and an additional 700,000 patients receive the devices each year. The Nanostim leadless pacemaker is less than 10 percent the size of a conventional pacemaker and designed to be implanted directly in the heart without the need for a surgical pocket or lead. The elimination of the visible lump and scar at a conventional pacemaker’s implant site, in addition to the removal of patient activity restrictions that may prevent the dislodgement or damage to a conventional lead, will potentially improve the quality of life for patients with this technology by allowing most to continue living active, uninhibited lifestyles.
“The Nanostim leadless pacemaker is one of the most important advances in the history of pacemaker technology,” said Dr. Mark Carlson, vice president of global clinical affairs and chief medical officer at St. Jude Medical. “The freedom from leads and now the ability for patients with the Nanostim leadless pacemaker to undergo MRI scans are important factors for physicians as they consider treatment options.”
Implanted via the femoral vein with the smallest available leadless technology delivery system, the Nanostim leadless pacemaker offers a less-invasive approach for physicians compared to traditional pacemaker procedures that require more invasive surgery. The device is designed to be fully retrievable so that it can be readily repositioned throughout the implant procedure and later retrieved if necessary.
The device is supported by the St. Jude Medical™ Merlin™ Programmer, which is also used to interrogate and program the company’s other pacemakers and implantable cardioverter defibrillators (ICDs).
In the coming months, St. Jude Medical anticipates updated labeling for many of its existing cardiac rhythm management devices, which will allow more patients the freedom to safely undergo MRI scans.
About the Nanostim™ Leadless Pacemaker
A pacemaker is a small implantable device that sends electrical pulses to the heart to treat bradycardia, which is a heart rate that is too slow. These devices monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements. Leadless pacemakers provide the same type of therapy but do so without the traditional leads found in conventional pacemakers.
The Nanostim leadless pacemaker operates like a traditional pacemaker, but is 10 percent the size of a conventional pacemaker and is designed to reduce or eliminate complications associated with leads, chest incisions and surgical pockets. The Nanostim leadless pacemaker received CE Mark approval in October 2013. To date, more than 1,000 Nanostim leadless pacemakers have been implanted worldwide. The Nanostim leadless pacemaker is undergoing a clinical study in the U.S. under an FDA-approved investigational device exemption.
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 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. 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
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
CES Asia 2018 Call for Speaker Proposals Now Open17.1.2018 21:37 | Pressemelding
The Consumer Technology Association (CTA) today announced that its Call for Speaker Proposals for CES Asia 2018 is now open. CES Asia seeks abstracts and speakers for the CES Asia conference program. Interested candidates, including subject matter experts from throughout Asia and across industries, have the opportunity to submit a conference proposal through February 14, 2018. Industry executives, futurists and visionaries in vehicle technology, financial tech, smart cities and other target technologies are encouraged to apply. Accepted proposals will be notified by April 2, 2018. Please review the full list of conference themes, submission guidelines and speaker overview before submitting. The CES Asia conference programming features over 30 conference sessions with more than 115 highly sought after industry experts from around the globe. CES Asia speakers present to an audience of high-level industry professionals, including 1,200 members of the global media. More than 40,000 people
STATS Announces Carl Mergele as Chief Executive Officer17.1.2018 17:04 | Pressemelding
Today, STATS, the worldwide leader in sports data and intelligence, announced the hiring of seasoned software executive, Carl Mergele as Chief Executive Officer. Mergele has extensive experience leading and growing software companies, providing world class products and excellent customer service across a number of sectors. In November 2016, Mergele was a software executive of publicly traded NYSE-company Lexmark International, Inc. which was sold to a consortium of private equity investors for $3.6 billion, following a number of software acquisitions in the preceding four years. In addition to leading software companies as CEO, including Vista-owned companies, Mergele has served as a board member to nearly two-dozen corporate entities. Mergele will oversee the company’s next phase of growth, empowering STATS’ customers—the most innovative and successful sports teams, leagues, and brands—with the best data, intelligence and technology, giving them an edge over their competition. “I am t
Intersolar and Power2Drive Europe 2018: Solar Power Generates Mobility17.1.2018 15:40 | Pressemelding
E-mobility is much more than just the clean mobility solution of the future. When electric vehicles are fueled by solar power, it also drives the deployment of photovoltaics forward. Intersolar Europe, the world’s leading exhibition for the solar industry, and Power2Drive Europe, the new exhibition for e-mobility and charging infrastructure, held June 20–22, 2018 in Munich, Germany under the umbrella of The smarter E Europe, will thus showcase the diverse prospects created for the environment by the combination of PV and e-mobility. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180117005988/en/ Solar Power generates mobility (Photo: Solar Promotion GmbH) Electric vehicles can be driven and charging stations can be fed with electricity from PV systems, making e-mobility a driver of the PV market. Ideally, electric vehicles are charged with solar power directly from the owner’s roof. For example, a PV system with a capacity of
Ascend Performance Materials Announces Price Increase for Nylon 6,6 Polymers, Compounds and Fibers17.1.2018 15:22 | Pressemelding
Ascend Performance Materials announced today a price increase for its nylon 6,6 polymers, compounds and fibers due to escalating raw material costs. The price increase takes effect Feb. 1, 2018, and includes the following price changes: Materials Geography Price Increase Terms Nylon 6,6 polymers, compounds and fibers North America $0.10/lb. As contracts allow Non-contract business – price determined on an order-by-order basis Nylon 6,6 polymers, compounds and fibers Europe €0.20/kg. As contracts allow Non-contract business – price determined on an order-by-order basis Nylon 6,6 polymers, compounds and fibers Asia $0.22/kg. As contracts allow Non-contract business – price determined on an order-by-order basis Customers should contact their local sales representative for additional information. About Ascend Performance Materials Ascend Performance Materials is a global premium provider of high-quality plastics, fibers and chemicals and is the world’s largest integrated producer of PA66 r
Mavenir Announces Virtualized Media Breakout Controller, Bringing 5G Edge Architectures to Legacy Networks17.1.2018 14:00 | Pressemelding
Mavenir, focused on transforming mobile network economics for Communications Service Providers, today announced its virtualized Media Breakout Controller (vMBC), a single white box routing platform that enables carriers to host virtual Routing, Firewall, and User plane data offload. Today’s networks, whether 3G, 4G or 5G, are under pressure to provide increased bandwidth in support of LTE and its frequency combinations, and reduce latency for network interaction, resulting in a continual need to increase capacity for traffic transported through the core of the network. Multi-Access Edge Computing standardization (MEC) is trying to resolve some of these issues by placing compute functionality at the edge but it is still mostly controlled from the core, based on conventional centralized architectures. The ability to scale network functionality using virtual elements and COTS HW platforms allows network functionality to be deployed at any location. Mavenir’s innovative solution offers the
WilsonHCG Unveils Fourth Annual Fortune 500 Top 100 Employment Brands Report17.1.2018 14:00 | Pressemelding
WilsonHCG, global leader and premium provider of innovative talent solutions, has revealed its 2018 Fortune 500 Top 100 Employment Brands report – the company’s fourth annual objective research, evaluation and ranking of how well Fortune 500 organizations brand themselves as an “employer of choice”. New to the 2018 report, WilsonHCG also analyzed the top 25 Global Fortune 500 employment brands. Based on six key employment branding categories and tens of thousands of data points, Johnson & Johnson earned the top overall ranking for the second year in a row (third consecutive top-10 performance). Intel earned the No. 2 overall spot, with three companies – IBM, Procter & Gamble and Lockheed Martin – tying for third overall. Rounding out the top 10 are General Motors, JPMorgan Chase, Dow, Cummins, and ADP (each tied for No. 6 overall). “We’re in the midst of the most competitive hiring environment of our time, as today’s talent has full transparency into what they're worth – and what compe
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom