Business Wire

First Patient Enrolled in Investigational Study of the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System

Jaa

W. L. Gore & Associates, Inc. (Gore) today announced the first implant of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the United States. The successful procedure took place on December 19, 2017 at Maimonides Medical Center in New York by Robert Rhee, MD, Chief of Vascular and Endovascular Surgery, and National Principal Investigator.

This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180103005266/en/

GORE® EXCLUDER® Conformable AAA Endoprosthesis (Photo: Business Wire)

GORE® EXCLUDER® Conformable AAA Endoprosthesis (Photo: Business Wire)

This EVAR device, which is the first to feature angulation control, is part of an investigational clinical study approved by the U.S. Food and Drug Administration (FDA). The clinical study will assess the safety and effectiveness of the device in treating infrarenal abdominal aortic aneurysms (AAA) in patients with challenging anatomy. The clinical study consists of two sub-studies, each assessing the device for a different range of patient anatomies. The implantation by Dr. Rhee is part of the short neck sub-study to assess the device in aortic neck angles of 0 to 60 degrees and aortic neck lengths of 10 mm or greater. The high neck angulation sub-study will evaluate proximal aortic neck angles of 61 to 90 degrees and aortic neck lengths of 10 mm or greater.

“Patients with extreme proximal neck anatomies often do not qualify for EVAR. Regardless of device flexibility, current delivery systems make it difficult to achieve conformability during deployment,” said Dr. Rhee. “The angulation control in the new delivery system for the GORE EXCLUDER Conformable AAA Device is intended to allow physicians a greater level of control to angle or bend the device to achieve orthogonal placement to the aortic blood flow lumen.”

The GORE EXCLUDER Conformable AAA Device builds on the proven clinical performance of the GORE® EXCLUDER® Device, which represents 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 GORE EXCLUDER Conformable AAA Device debuts the GORE® ACTIVE CONTROL System into the abdominal aorta. This delivery system includes angulation control, giving physicians the option to angle or bend the device to achieve orthogonal placement to the aortic blood flow lumen and to maximize the conformability and seal of the device. Like the GORE® C3® Delivery System, the GORE ACTIVE CONTROL System offers the ability to reposition the device if needed after initial deployment to achieve optimal device placement.

“This implant is the latest step in our continuing efforts to offer the broadest and most technically advanced endovascular treatment capabilities on the market,” said Eric Zacharias, Vascular Business Leader. “Since bringing our first EVAR device to market two decades ago, Gore has been committed to providing innovative solutions that expand the endovascular treatment of aortic disease. In collaborating with our physician partners, we heard that highly angulated anatomy can challenge the ability of currently available EVAR devices to achieve an optimal seal. The IDE study will evaluate the ability of the system to fill the unmet need for an EVAR device to treat that anatomy. The system combines the nesting stent design proven successful in the Conformable GORE® TAG® Thoracic Endoprosthesis with the repositionability of the GORE C3 Delivery System, while the new angulation control feature meets the need for an EVAR device that can treat more challenging anatomies."

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 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 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis, the first FDA approved balloon-expandable stent graft for treatment of de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation.

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.

* 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 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 9,500 Associates and generates annual revenues that exceed $3 billion. www.gore.com

Products listed may not be available in all markets.
GORE ® , GORE-TEX ® , ACTIVE CONTROL, C3 ® , EXCLUDER ® , TAG ® , VBX, and VIABAHN ® are trademarks of W. L. Gore & Associates.

Contact information

Media:
Bliss Integrated Communication for Gore Medical
Claire LaCagnina, 212-840-8079
Claire@blissintegrated.com
or
Liz DeForest, 212-584-5477
Liz@blissintegrated.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

PSE: APM Forum 2018 Focus on Digitalisation for the Process Industries20.4.2018 18:13Tiedote

At the 2018 Advanced Process Modelling (APM) Forum this week, process industry organisations presented on digital design and operations applications ranging from accelerating development of the next generation of pharmaceuticals to realising millions of dollars per year in increased profit for large process plants. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180420005517/en/ Ben Weinstein, head of R&D Product and Process Systems Modeling at Procter & Gamble, delivers the keynote speech on how digital design techniques are used systematically to accelerate innovation in P&G. (Photo: Business Wire) Introducing the conference, Prof. Costas Pantelides, MD of conference host Process Systems Enterprise (PSE), described the current wave of digitalisation as the culmination of many years of advanced modelling and IT development. “This is a time of extraordinary opportunities for the process industries” he said. Keynote speaker Ma

Aperta Provides Electronic Funds Transfer (EFT) in Cayman Islands20.4.2018 17:01Tiedote

Once again, the Aperta Active Clearing System (ACS) has delivered the mechanism for a country to implement a world-class electronic payment processing environment to maximize a national payments system’s efficiency, effectiveness, security and control. Aperta partnered with the Cayman Islands ACH Operator (Prism Services (Cayman) Ltd.) and local commercial banks to deliver a new Electronic Funds Transfer system. The old process of banks swapping files in a wide-variety of standards and settling bilaterally has been replaced with a common system and standards, employing international-standard secure file transfer protocol, allowing participants to monitor real time net settlement and collateral positions via a secure portal. The Cayman Islands Automated Clearinghouse (CIACH) links all six of the country’s banks and provides the central clearing and settlement mechanism for banks to exchange direct debit and direct credit transactions seamlessly across the country. It is functionally NAC

FII Tech Growth Invests in SECO20.4.2018 16:39Tiedote

FII Tech Growth, a fund managed by Fondo Italiano d’Investimento SGR, announces today its second investment in SECO SpA, one of the European leaders in the embedded electronics market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180420005413/en/ (Photo: SECO) SECO, headquartered in Arezzo, Tuscany, with subsidiaries in the U.S.A., Germany and Taiwan, was founded in 1979 by entrepreneurs Daniele Conti and Luciano Secciani. The company designs and manufactures micro-computers and integrated systems for industrial applications. With more than 250 employees, SECO supports customers with a worldwide presence such as Cimbali, Esaote, Technogym and Vimar, and generated revenue in excess of Euro 50 million in 2017. The ability to offer innovative solutions by using cutting-edge technologies has allowed SECO to grow steadily over time. The company developed a network of collaborations with universities and research centres La Sapi

Schlumberger Announces First-Quarter 2018 Results20.4.2018 14:05Tiedote

Schlumberger Limited (NYSE:SLB) today reported results for the first quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Mar. 31, 2018 Dec. 31, 2017 Mar. 31, 2017 Sequential Year-on-year Revenue $7,829 $8,179 $6,894 -4% 14% Pretax operating income $974 $1,155 $757 -16% 29% Pretax operating margin 12.4% 14.1% 11.0% -169 bps 145 bps Net income (loss) - GAAP basis $525 $(2,255) $279 n/m 88% Net income, excluding charges & credits* $525 $668 $347 -21% 51% Diluted EPS (loss per share) - GAAP basis $0.38 $(1.63) $0.20 n/m 90% Diluted EPS, excluding charges & credits* $0.38 $0.48 $0.25 -21% 52% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Schlumberger Chairman and CEO Paal Kibsgaard commented, “As forecast, our results in the first quarter of 2018 largely reflected transitory factors, with seasonal reductions in activity in the Northern Hemisphere and planned project startup costs

Biogen and Ionis Expand Strategic Collaboration to Develop Drug Candidates for a Broad Range of Neurological Diseases20.4.2018 13:30Tiedote

Biogen (Nasdaq: BIIB) and Ionis Pharmaceuticals (Nasdaq: IONS) announced today they have expanded their strategic collaboration through a new ten-year collaboration agreement to develop novel antisense drug candidates for a broad range of neurological diseases. This collaboration capitalizes on Biogen’s expertise in neuroscience research and drug development and Ionis’ leadership in RNA targeted therapies with the goal of developing a broad pipeline of investigational therapies. It builds upon a productive collaboration that produced SPINRAZA, the first and only approved treatment for patients with spinal muscular atrophy. Today, April 20, 2018, Biogen and Ionis will host company conference calls and webcasts to discuss the new collaboration. Full webcast details can be found below. Under the terms of the collaboration, Biogen will pay Ionis $1 billion in cash, which will include $625 million to purchase 11,501,153 shares of Ionis common stock at a price of $54.34 per share, at an appr

Versum Materials Celebrates the Grand Opening of Its Research and Development Facility in Hometown, PA19.4.2018 23:37Tiedote

Versum Materials, Inc. (NYSE: VSM), a leading materials supplier to the semiconductor industry, announced today the grand opening of its new research and development (R&D) facility at its semiconductor materials manufacturing site in Hometown, Pennsylvania. The ribbon-cutting ceremony took place April 10, 2018. Versum employees, members of the community, local government, customers and strategic partners attended the event. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180419006305/en/ Versum Materials ribbon-cutting ceremony at the company's new R&D facility in Hometown, PA. (Photo: Business Wire) The state-of-the-art R&D laboratory is dedicated to new materials used in the manufacture of semiconductors. Scientists in the facility will synthesize and purify new molecules down to parts per billion impurity levels and below using the latest technologies available in the industry. The researchers can assess the applications f

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme