First Patient in Europe Receives Implant of GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System and Enrolls in Post-Market Registry
W. L. Gore & Associates, Inc. (Gore) today announced the first European patient implant of the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System. This next-generation endovascular aneurysm repair (EVAR) device is indicated to treat the broadest range of abdominal aortic aneurysms (AAA) in patients with challenging anatomies. Physicians now have an EVAR solution designed to treat patients previously excluded due to challenging proximal aortic necks.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180917005087/en/
GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System (Graphic: Business Wire)
The GORE EXCLUDER Conformable AAA Endoprosthesis with ACTIVE CONTROL System is CE Mark approved for patients with proximal aortic neck angles of up to 90 degrees with a minimum 15 mm aortic neck length or in patients with proximal aortic neck angles of up to 60 degrees with a 10 mm minimum aortic neck length.
The successful procedure took place on September 11 at Catharina Hospital in Eindhoven, Netherlands by Marc van Sambeek, MD. The patient was also the first enrollment in an investigator initiated post-market European registry, known as EXCeL (EXcluder Conformable real Life), of which Prof. van Sambeek is the principal investigator.
“Before this device, EVAR was reserved for patients whose aorta fell within a standard shape and size,” said Prof. van Sambeek. “The conformability of the new GORE EXCLUDER Conformable Device in combination with the angulation control of the new delivery system will allow us to offer a less invasive, lower-risk alternative to open surgery to more AAA patients than ever before. The EXCeL registry will track the real-world effectiveness and safety of the device, and I look forward to enrolling additional patients with challenging, highly angulated aortic anatomies and seeing the long-term value of this device.”
The EXCeL registry will enroll 150 patients from up to 11 European sites. Data from the registry will assess safety and treatment success of the GORE EXCLUDER Conformable AAA Device for the treatment of infrarenal AAA in a broad range of anatomic presentations. The device is also currently being evaluated in a pivotal investigational U.S. study, in which the first patient was enrolled on December 19, 2017.
The GORE EXCLUDER Conformable AAA Device builds on the proven clinical performance of the GORE® EXCLUDER® AAA Endoprosthesis, which represents over 20 years of worldwide experience and more than 300,000 patients treated*, a history unmatched by currently available AAA stent grafts. The new device leverages the limb design of the GORE EXCLUDER Device which has demonstrated exceptional clinical performance as evidenced by 0.5% limb occlusion through 3-year follow-up.** The limbs, a unique combination of proprietary ePTFE graft material and a fully supported, nested, nitinol stent, are designed to prevent kinking and occlusion.
The new device introduces the GORE® ACTIVE CONTROL System in AAA treatment. This new delivery system includes a conformable stent graft, enhanced device positioning, and optional angulation control. To enhance positioning, the device is deployed partially constrained and the physician has the option to reconstrain the proximal end of the device to aide in achieving optimal device placement. During the deployment process, the physician may use the optional angulation control to angle the device to achieve orthogonal placement to the aortic blood flow lumen and to maximize device conformability and seal.
“With this first implant in Europe, we are continuing our commitment to offer the broadest and most technically advanced endovascular treatment capabilities to physicians and their patients,” said Eric Zacharias, Vascular Business Leader. “We are dedicated to developing technology that enables physicians to better treat challenging aortic anatomies. By collaborating with physicians, we’ve evolved our market-leading GORE EXCLUDER Device to enable more patients to be treated with EVAR.”
The GORE EXCLUDER Conformable AAA Device is part of the growing family of endovascular products that share a mission to effectively treat aortic disease, backed by Gore’s highly rated clinical support team and educational offerings.† The comprehensive portfolio of products also includes the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System for the treatment of thoracic aneurysms, transections, and Type B dissections; the GORE® EXCLUDER® Iliac Branch Endoprosthesis, the first complete, all-in-one system approved in Europe for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms; and the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis for treatment of de novo or restenotic lesions, including lesions at the aortic bifurcation.
* Based on the number of Trunk-Ipsilateral Legs distributed.
** 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 complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).
MEDICAL PRODUCTS DIVISION
Gore 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 global recognition from the Great Place to Work® Institute. Headquartered in Newark, Del., Gore employs 9,500 Associates and generates annual revenues of $3.5 billion. www.gore.com
Products listed may not be available in all markets.
GORE ® , GORE-TEX ® , ACTIVE CONTROL, EXCLUDER ® , TAG ® , VBX, and VIABAHN ® are trademarks of W. L. Gore & Associates. AX0416-EN1 SEPTEMBER 2018
Bliss Integrated Communication for Gore Medical
Liz DeForest, 212-584-5477
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
Boehringer Ingelheim and OSE Immunotherapeutics Announce Dosing Of the First Patient in a Phase 1 Trial of SIRPα Antagonist Monoclonal Antibody, BI 765063, in Patients with Advanced Solid Tumors17.6.2019 16:00:00 CEST | Pressemelding
Boehringer Ingelheim and OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) today announce that the first patient has been dosed in the first-in-human Phase 1 clinical trial evaluating BI 765063, formerly OSE-172, a first-in-class monoclonal antibody antagonist of SIRPα, being studied in patients with advanced solid tumors. The Phase 1 study is a dose finding study of BI 765063, a myeloid checkpoint inhibitor, administered as a single agent and in combination with Boehringer Ingelheim’s monoclonal antibody PD-1 antagonist BI 754091, a T-lymphocyte checkpoint inhibitor. “We are very pleased with the progress achieved on BI 765063’s program and having the first patient dosed marks a significant milestone in the product’s development. The advancement of a myeloid cell checkpoint blocking monoclonal antibody into the clinic exemplifies Boehringer Ingelheim’s commitment to the next wave of innovation in cancer immunology therapies, with the goal of meaningfully improving outcomes fo
MagicStay Raises €3 Million to Accelerate Its International Development17.6.2019 15:58:00 CEST | Pressemelding
The apartment rental platform dedicated to business travelers, MagicStay.com , announces its full integration into the main business travel booking tools and a €3 million A-series to pursue its development, bringing the amounts raised to more than €8 million since its launch in 2013. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190617005644/en/ William Lecerf and Valéry Linyer, co-founders of MagicStay (Photo: MagicStay) "This fundraising will allow us to recruit talent to accelerate our growth. We want to sign a quarter of the major French companies and approach one million homes before the end of the year, thanks to the exclusive technologies we now have at our disposal", says Valéry Linÿer, CEO and co-founder, who adds: "We have four main advantages over our competitors: we meet the challenges of duty of care, we are able to customize our tool to meet the constraints of each large company for short and long stays, we ha
EURid Shows a 94% Reduction of Its Footprint since 201217.6.2019 15:32:00 CEST | Pressemelding
EURid, the not-for-profit organisation that operates the .eu and .ею top-level domains, is the first European TLD registry that registered for the EU Eco-Management and Audit Scheme (EMAS) from 2011. Since then, EURid has regularly assessed the environmental impact of its activities and monitored the compliance of its policies and procedures. As over the past four years, in Q2 2019 EURid was audited for the CO2 emissions of the previous year, resulting in an overall footprint of 135 tons CO2eq, which shows a 94% reduction since 2012. “We have achieved carbon neutrality via several actions and the compensation of the audited emissions. We were and are still among the first in our sector to report on our commitment to protect the environment”, commented CEO Marc Van Wesemael. Through EMAS, EURid has had the opportunity to support a multitude of global sustainability initiatives, like the Ugandan Borehole Project, Ecomapuà Project in the Amazon, the Dak Rung Hydropower Project in Vietnam,
Animation, Sound & Vibration – How Visa is Reinforcing Consumer Trust in a Changing Payments World17.6.2019 15:00:00 CEST | Pressemelding
Visa (NYSE: V) today announced global adoption of its sensory branding suite in 25 countries via more than a dozen new partnerships. The suite is comprised of sound, animation and haptic brand cues that occur with a Visa payment transaction. In a digital world increasingly filled with voice-commands, networked appliances and unattended retail environments, Visa’s sensory branding cues offer new ways to enhance the customer experience and convey the trust and security that the Visa brand represents. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190617005240/en/ Visa was the first major payment brand to introduce multi-sensory branding, which included animation, sound and haptic vibration expressions of its brand. After an extensive creation and selection process that involved focus groups and elimination rounds, Visa landed on a single ‘energetic’ and ‘optimistic’ sound, and complementary animation and haptic vibration. Sinc
Study from Project Management Institute Identifies Six AI Technologies Impacting Project Professionals17.6.2019 14:40:00 CEST | Pressemelding
Project Management Institute (PMI) today released its 2019 Pulse of the Profession® In-Depth Report: AI Innovators: Cracking the Code on Project Performance. The report provides an in-depth look at how artificial intelligence (AI) is impacting organizations and the project management profession. Findings reveal that AI disruption is happening and at a large scale: 81 percent of respondents report their organization is being impacted by AI technologies; 37 percent say adopting AI technologies is a high priority for their organization; and project professionals say they expect the proportion of the projects they manage using AI will jump from 23 to 37 percent over the next three years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190617005558/en/ These insights from a survey of 551 project management practitioners globally show that the presence of AI technologies will continue to grow, requiring shifts in how projects are m
RIBOMIC Announces Positive Top-Line Results from the Phase 1/2a Clinical Trial of RBM-007 (SUSHI Study) in Subjects with Wet Age-Related Macular Degeneration17.6.2019 13:15:00 CEST | Pressemelding
RIBOMIC, Inc., a clinical stage pharmaceutical company specializing in aptamer therapeutics and traded on the Mothers Market of the Tokyo Stock Exchange (Code Number: 4591), today announced positive top-line results from its SUSHI study, Phase 1/2a single ascending dose clinical study of RBM-007, anti-FGF2 aptamer, in nine subjects with wet Age-Related Macular Degeneration (wet AMD). SUSHI study achieved the primary endpoint of safety and tolerability, and also demonstrated efficacy trends in favor of RBM-007. Subjects recruited for the SUSHI Study had wet AMD that was poorly responsive to previous intravitreal anti-VEGF therapy. Through the 56-Day exit visit, excluding one uncompleted case in the last cohort, single dose of RBM-007 demonstrated no dose-limiting toxicities, no systemic or ocular serious adverse events. One subject in Cohort 3 showed anterior inflammation, which was resolved after one day of topical prednisolone treatment. Rescue treatment with anti-VEGF therapy was ava