New Data Presented at EuroPCR 2016 Adds to the Growing Body of Clinical Evidence Supporting St. Jude Medical FFR Technology and LAA Closure
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced results from two cardiovascular clinical trials presented at EuroPCR 2016. The studies, which include a look at how St. Jude Medical™ fractional flow reserve (FFR) technology impacts patient outcomes in Acute Coronary Syndrome (ACS) and a comparison of left atrial appendage occlusion (LAAO) therapy to standard medical treatment – were presented during hotline sessions.
The latest studies contribute to the growing body of evidence supporting two important St. Jude Medical cardiovascular therapies: FFR guidance with St. Jude Medical PressureWire™ technology to optimize percutaneous coronary intervention (PCI) procedures in patients with narrowed or blocked coronary arteries, as well as left atrial appendage closure for patients at increased risk of stroke as a result of atrial fibrillation. St. Jude Medical has been an international leader in LAAO therapy, originally offering the AMPLATZER™ Cardiac Plug (ACP) for LAAO and now offering the AMPLATZER™ Amulet™ Left Atrial Appendage Occluder.
PRIME-FFR Study showcases the benefits of FFR in the Treatment of ACS
Presented today at a EuroPCR Hotline session, the PRIME-FFR study aimed to quantify the value of FFR when deciding the most appropriate treatment for patients with ACS. In the medical community, ACS is an umbrella term for medical conditions where blood supply to the heart is suddenly blocked. According to the American Heart Association, the blockage can be sudden and clog the entire artery or it can be a moving clot that causes temporary blockage and decreased blood supply. The condition is more commonly referred to as a heart attack and needs to be addressed by a physician immediately.
In assessing the value of FFR, the study’s investigators defined management strategies for patients based on angiography results before performing FFR, and then made a final treatment strategy decision after performing FFR. Results showed that management strategy reclassification after performing routine FFR was high and that FFR is safe to use in ACS patients, indicating a management strategy guided by FFR safely leads to changes in physician decision making.
“These data further support the benefits of the St. Jude Medical fractional flow reserve portfolio and show that using our fractional flow reserve technology as part of a management plan helps physicians make informed treatment decisions,” said Dr. Mark Carlson, chief medical officer and vice president of global medical affairs at St. Jude Medical. “We are committed to providing the best treatment options for our patients and technology like this allows us to do so.”
Assessing the impact of St. Jude Medical’s LAAO technology versus standard medical therapy in patients with atrial fibrillation and intracerebral hemorrhage
In a hotline presentation at EuroPCR, researchers assessed the impact of a LAAO in patients with atrial fibrillation (AF) and intracerebral hemorrhage (ICH) versus patients who received standard medical therapy. The left atrial appendage (LAA) is a small pouch that hangs from the left atrium, which is considered to be unproblematic for most people with a regular heart rhythm. However, patients with AF experience a chaotic, uncontrolled heart rhythm, which can increase the likelihood of clot formation in the LAA, potentially resulting in a stroke. Because AF leads to an increased risk of stroke, a physician may seal off the LAA with an LAA Occluder, or prescribe oral anticoagulants (OAC) to potentially reducing that risk.
While OACs are proven to be effective in reducing the risk of stroke in patients with AF, this therapy carries the risk of ICH, or recurrent bleeding, which is the leading cause of stroke mortality. Because the risk of reoccurring ICH is increased among patients who have previously experienced an ICH, many of these patients are denied OAC.
The LAAO in AF and ICH study found that patients with AF and a prior ICH who were treated with a St. Jude Medical LAAO device had a lower risk of ischemic stroke, major bleeding and all-cause mortality compared to patients treated with standard care, suggesting that LAAO offers a major clinical benefit.
“Patients with atrial fibrillation and previous intracerebral hemorrhage have an increased risk of ischemic stroke or repeated hemorrhage,” said Jens Erik Nielsen-Kudsk, M.D., DMSc, an associate professor of cardiologic medicine at Aarhus University and the study’s lead author. “The data from the this latest clinical assessment further shows that having a device like the AMPLATZER LAA occlusion device implanted in these patients’ hearts offers them additional opportunity for improved cardiac health.”
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, 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 April 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
(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
JustPremium Launches Rich Video Product Suite19.3.2018 08:00 | Pressemelding
Programmatic rich media and video ad marketplace, JustPremium, has today announced the launch of a new product suite, Rich Video. The new offering allows clients to build multiple rich video ad units with a single click using the advertisers existing assets. Using Rich Video allows advertisers to create an engaging advert, leading to higher engagement and interaction rates. Ultimately these formats help create a better user experience and a higher return on investment. JustPremium launches this product at a time when quality video inventory has never been more in demand, and brand-safe video inventory that advertisers require has never been in shorter supply. Rich Video allows publishers to build multiple creative ad units in minutes, enabling them to test different options and optimise their message to give the best performance. By utilising the assets that have already been created for Facebook, Adwords and YouTube, this process allows advertisers to supercharge their existing conten
GovSat-1 Satellite Goes Operational19.3.2018 07:40 | Pressemelding
GovSat-1 enters operational service today, to provide secure communications to governmental and institutional users. GovSat-1 is the first satellite of GovSat, a public private partnership between the Government of Luxembourg and the world-leading satellite operator SES. The satellite was launched into space on 31 January on board a flight-proven SpaceX Falcon 9 rocket from Cape Canaveral Air Force Station, and has since undergone extensive testing. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180319005458/en/ GovSat-1 launch. (Photo: SpaceX) The multi-mission satellite is operated by GovSat from the Secure Mission Operations Centre in Luxembourg. The highly flexible and resilient GovSat-1 payload uses dedicated frequencies in X-band and military Ka-band. It enables an array of applications such as connectivity for theatres of operation, interconnection of institutional or defence sites, border control, Intelligence, Surve
Digi Communications N.V.: Announcement on the Convocation Date for the Company’s GSM Approving the 2017 Annual Report19.3.2018 07:34 | Pressemelding
The Company would like to inform its investors and the market that the Board of Directors anticipates that on Wednesday, 21 March 2018, it will convene the general shareholders meeting (the “GSM”) called to approve, among others, the 2017 Annual Report. On the same date, the Company will make public, among others, its 2017 Annual Report and the auditor’s report. In accordance with the provisions of the articles of association of the Company, the GSM is scheduled to take place on 2 May 2018. Therefore, we would like to inform you with respect to the update to the Company’s Financial Reporting Calendar for 2018, which is available on Digi’s website. For details, please access the Digi’s website: www.digi-communications.ro (Investor Relations Section). About Digi Communications NV Digi is the parent holding company of RCS & RDS, a leading provider of pay TV and telecommunications services in Romania and Hungary. In addition, RCS & RDS provides mobile services as an MVNO to the large Roman
Dai Nippon Printing Chooses Gemalto’s Biometric Facial Recognition Solution to Facilitate Mobile Banking Access in Japan19.3.2018 06:00 | Pressemelding
Gemalto, the world leader in digital security, today announced that it has been selected by Dai Nippon Printing (DNP), a financial solutions provider in Japan, to make mobile banking transactions easier to use. Leveraging Gemalto’s facial biometric authentication solution - Mobile Protector- DNP has started to offer facial recognition to secure access to its mobile banking apps. This enables banking customers to easily and quickly log on to mobile banking services upon successful facial authentication, providing a more convenient user experience. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180318005005/en/ Facial recognition for mobile banking authentication. (Photo: Gemalto) Gemalto’s 2017 eBanking Trends research found that 68 percent of banks plan to implement facial recognition over the next five years. 80 percent of surveyed consumers perceived biometrics to be more secure than the traditional username and password co
Gemalto Helps European Banks Build Business Opportunities from PSD219.3.2018 06:00 | Pressemelding
Gemalto, the world leader in digital security, believes that the implementation of PSD2 (Payment Services Directive 2) offers European banks a unique opportunity to deliver digital innovation, robust protection and seamless user experience that will be critical in a new era of open markets. The Regulatory Technical Standards (RTS) have just been published in the EU Official Journal, and detail the responsibilities and obligations of all banking and payment stakeholders concerning access to account, customer data protection, user convenience, and payment security. Gemalto believes that long term success will be built around solutions tailored to individual requirements, whilst drawing on products and services already proven to deliver the core principles of PSD2. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180318005025/en/ Solutions to help financial institutions for implementation of PSD2. Credit: istockphoto Adoption of t
ExThera Medical Announces Creation of European Subsidiary19.3.2018 05:23 | Pressemelding
ExThera Medical Corporation, a developer of therapies for removing bacteria and viruses from blood, today announced the company’s plan to create ExThera Medical Europe and appointed Carla Kikken-Jussen as managing director of the new wholly-owned subsidiary. Carla brings more than 30 years of experience in clinical research and the commercialization of new medical devices in the European market to ExThera Medical, where she will oversee the strategic direction for ExThera’s European operations. “The establishment of our European subsidiary is an exciting milestone as we prepare for commercialization,” said Robert Ward, President and CEO of ExThera Medical. “Carla has a distinguished track record in medical device development and commercialization, including overseeing clinical research, regulatory affairs, quality assurance, and operations. As CEO of her company, Meditech, she successfully supported the rapid clinical adoption of many new medical devices. Carla’s strategic leadership w