Celebrating the 20th Anniversary of the GORE® EXCLUDER® Device
W. L. Gore & Associates, Inc. (Gore) today announced the 20th anniversary of the first implant of the GORE® EXCLUDER® AAA Endoprosthesis, the most-studied** endovascular aneurysm repair (EVAR) device on the market, with more than 300,000 patients treated* worldwide. The GORE EXCLUDER Device provides physicians with a proven and durable option to treat patients diagnosed with AAA, a condition that threatens tens of thousands of lives each year. The GORE EXCLUDER Device has demonstrated exceptional clinical performance as evidenced by 96% freedom from device-related reintervention and 0.5% limb occlusion through 3-year follow-up.†
“Gore is known as a pioneer and leading innovator in the EVAR field, which has rapidly expanded over the past two decades, reducing the surgical and recovery time required for most patients treated for AAA,” said Michael Marin, MD, Chairman and Professor of Surgery at Icahn School of Medicine at Mount Sinai.
The GORE EXCLUDER Device received CE Mark in Europe in 1997 and FDA approval in 2002. The first in-human implant of the device was performed in September, 1997. In 2004, Gore introduced the low-permeability GORE EXCLUDER Device, which remains in use today. In 2010, Gore advanced the accuracy of EVAR with the GORE® C3® Delivery System, which allows more precise and controlled deployment to obtain an optimal seal. Since then, the device has undergone further advancements to broaden the applicability and value to more patients by expanding the portfolio of sizes and reducing delivery profile. These enhancements, along with a flexible, low-profile delivery catheter, have made the GORE EXCLUDER Device a U.S. market leader for EVAR devices. Based on the company-sponsored trials and registries, the GORE EXCLUDER Device is the most studied** of all currently available stent grafts for AAA, with two decades of proven efficacy, safety, and long-term outcomes evidence.
“With its proven durability, precise delivery system, and 20 years of clinical implant experience, I have come to trust and rely on the GORE EXCLUDER Device in my practice. I look forward to seeing the future innovations Gore brings to EVAR as well as the endovascular treatment of the entire aorta,” said Dr. Claudio Schönholz, Professor of Radiology and Surgery at the Medical University of South Carolina.
“The GORE EXCLUDER Device has truly stood the test of time with a design that has continued to deliver performance and iterations of that design have kept the device as the leading EVAR solution over many years,” said Eric Zacharias, vascular business leader at Gore. “While we are happy to celebrate the history of this product, we also remain committed and focused on the future, and look forward to continuing to provide transformative solutions to the challenges of vascular disease.”
The GORE EXCLUDER AAA Endoprosthesis is part of the growing family of endovascular products that share a mission to effectively treat vascular disease, backed by Gore’s highly rated clinical support teams and educational offerings.†† The comprehensive portfolio of products includes the Conformable GORE® TAG® Thoracic Endoprosthesis for the treatment of thoracic aneurysms, transections, and Type B dissections; the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE), the first FDA approved off-the-shelf device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms; the GORE® VIABAHN® Endoprosthesis, the market-leading stent graft for the treatment of complex peripheral vascular disease; and the recently FDA approved GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis for treatment of de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation, the first and only balloon-expandable stent graft with an indication for the iliac artery. For potential additions to Gore’s branched portfolio, investigational studies are ongoing for the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE), and enrollment continues in the GORE® TAG® Thoracic Branch Endoprosthesis (TBE) Pivotal Study to assess safety and effectiveness in treating lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel. Both of these are investigational devices that are not yet approved for commercial sale.
For more information on the treatment of aortic aneurysms including AAA, visit www.goremedical.com/aortic.
* Based on the number of Trunk-Ipsilateral Legs distributed.
** Based on company-sponsored trials and registries shown on clinicaltrials.gov for currently available stent grafts.
†GREAT. n = 3,273. To calculate the overall event rates from procedure through end of study period, all subjects who could have had events, regardless of length of follow-up, were included. For outcome data, GREAT only collects site reported serious adverse events.
†† For Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU) and / or goremedical.com.
MEDICAL PRODUCTS DIVISION
Gore Medical Products Division engineers devices that treat a range of cardiovascular and other health conditions. With more than 40 million medical devices implanted over the course of more than 40 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives. www.goremedical.com
ABOUT W. L. GORE & ASSOCIATES
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Founded in 1958, Gore has built a reputation for solving complex technical challenges in the most demanding environments — from revolutionizing the outerwear industry with GORE-TEX® fabric to creating medical devices that improve and save lives to enabling new levels of performance in the aerospace, pharmaceutical and mobile electronics markets, among other industries. The company is also known for its strong, team-oriented culture and continued recognition from the Great Place to Work® Institute. Headquartered in Newark, Del., Gore employs approximately 10,000 Associates and generates annual revenues that exceed $3 billion. www.gore.com
Products listed may not be available in all markets.
GORE®, GORE-TEX®, C3®, EXCLUDER®, TAG®, VBX, and VIABAHN® are trademarks of W. L. Gore & Associates. OCTOBER 2017 AW1530-EN1
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
American Airlines Announces Nonstop Philadelphia (PHL) to Orlando Melbourne (MLB)21.9.2018 22:13 | Pressemelding
Glorious beaches by day and theme park fireworks by night just got more convenient for Philadelphia travelers. American Airlines announced today that it will begin nonstop flights to Orlando Melbourne International Airport (MLB) starting February 16, 2019. The Central Florida airport is conveniently located in the heart of the tourism region and is the closest airport to NASA rocket launches, Port Canaveral’s cruises and what critics call “some of the most beautiful beaches Florida has to offer.” The flights will depart Saturdays from Philadelphia at 8:05 a.m., arriving in Florida at 10:48 a.m. The Embraer 175 jet arrival time syncs perfectly with cruise ship noon early boarding. Melbourne Airport Express offers nonstop shuttle service to the port, and all major rental car companies are onsite. The return flight to PHL departs at 11:24 a.m. and arrives in PHL at 1:55 p.m., with enough time to connect to some of American’s largest international destinations, including recently announced
Amy Palladino Joins BCW as Executive Vice President, Managing Director, Corporate Practice21.9.2018 17:43 | Pressemelding
BCW (Burson Cohn & Wolfe), a leading global communications agency, today announced that Amy Palladino has joined the agency as Executive Vice President, Managing Director in the agency’s U.S. Corporate Practice. Based in New York, Palladino will focus on senior client counsel and executive positioning for the agency’s largest corporate clients. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005507/en/ Amy Palladino Joins BCW (Burson Cohn & Wolfe) “Amy is a talented and highly experienced communications executive with a track record of solving clients’ complex challenges and building business through smart, integrated communications approaches,” said Chris Foster, President, North America, BCW. “Her creativity and judgement will be enormously valuable to our current and prospective clients.” Palladino has more than 20 years of experience advising global clients across numerous industries, including technology, healthcar
Heidelberg Engineering Announces the CE-Marking of ANTERION21.9.2018 16:41 | Pressemelding
Heidelberg Engineering, the leader in diagnostic imaging known for the internationally-acclaimed SPECTRALIS ® retina and glaucoma platform, announces the CE-marking of ANTERION ® – an innovative platform designed to transform anterior segment diagnostics and workflow. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005442/en/ The new Heidelberg Engineering ANTERION® provides the most important anterior segment examinations and measurements in one modular, upgradeable platform. (Graphic: Business Wire) The new ANTERION provides the most important anterior segment examinations and measurements in one modular, upgradeable platform. It is a single, workflow-efficient solution that brings together corneal topography and tomography, anterior segment metrics, axial length measurement and IOL calculation to transform the day-to-day routine of busy practices and clinics. Heidelberg Engineering has leveraged its core OCT technolo
Florian Winterstein Becomes New CEO of Jedox21.9.2018 15:46 | Pressemelding
The supervisory board of Jedox AG, a leading vendor of business intelligence and enterprise planning software, has appointed Florian Winterstein as Chief Executive Officer (CEO) effective October 2, 2018. This nomination will support Jedox’s international growth and a new development phase initiated by its latest fund raising in April 2018 with Iris Capital, eCAPITAL entrepreneurial Partners AG and Wecken & Cie. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005416/en/ Florian Winterstein (Photo: Business Wire) With 25 years of experience in strategy consulting and leadership in software and service organizations, Winterstein brings to the company a valuable combination of expertise in cloud solutions, business development, and value creation for customers and partners. As former Chief Strategy Officer of BravoSolution, he positioned the software-as-a-service company as trendsetting digitalization partner, extending it
Takeda Receives Positive CHMP Opinion Recommending ALUNBRIG® (brigatinib) for the Treatment of ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with Crizotinib21.9.2018 13:30 | Pressemelding
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the full approval of ALUNBRIG® (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. ALUNBRIG is a tyrosine kinase inhibitor (TKI) designed to target and inhibit the ALK mutation in NSCLC. Approximately three to five percent of NSCLC patients globally have the ALK mutation. If the CHMP opinion is affirmed, and the European Commission approves ALUNBRIG, it will become the only ALK inhibitor available in the European Union as a one tablet per day dose that can be taken with or without food. The randomized, global Phase 2 ALTA trial was designed to investigate the efficacy and safety of ALUNBRIG in patients with locally advanced or metastatic ALK+
Asda Selects HCL Technologies to Help Drive IT Transformation21.9.2018 12:16 | Pressemelding
HCL Technologies (HCL), a leading global technology company, today announced that it has been selected to help drive IT transformation at the UK’s third-largest grocery retailer, Asda. The three-year application services contract will see HCL transform Asda’s IT Application Services with a new DevOps delivery model to drive data and analytics and support back-office applications through the full lifecycle of development, testing and support. HCL will also build a central data management platform to enable Asda to improve its insight and analytics capabilities. Asda operates more than 600 stores across the UK, employing over 135,000 people. Asda wanted to adopt a more agile approach towards application development and testing. This would allow the company to respond faster to business requirements and reduce time to market, while driving better user experience and satisfaction. HCL was selected due to its extensive expertise in successfully delivering similar large scale IT transformati