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

Loxam Announces a Conditional Agreement to Acquire UK Platforms20.7.2018 17:51Tiedote

Loxam Group (“Loxam”) announces that its wholly-owned subsidiary Nationwide Platforms Limited (“Nationwide”) has entered into a conditional agreement with HSS Hire Group plc (“HSS”) with respect to the acquisition of UK Platforms Limited (“UKP”). UKP specializes in renting powered access equipment from its 12 branches located throughout the United Kingdom. The company has approximately 130 employees and operates a fleet of 3,000 units. UKP is controlled by HSS since 2013. As part of this transaction, Nationwide has entered into a commercial agreement with HSS to provide powered access equipment to complement HSS’ existing fleet. The closing of the transaction is subject to the approval by HSS’ shareholders and the confirmation that it will not be referred to the Competition and Mergers Authority. The transaction is expected to close before year end 2018. Don Kenny, CEO of Loxam’s Powered Access Division states: “I am delighted with the acquisition of UKP which will further reinforce NW

Schlumberger Announces Second-Quarter 2018 Results20.7.2018 14:00Tiedote

Schlumberger Limited (NYSE: SLB) today reported results for the second quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Jun. 30, 2018 Mar. 31, 2018 Jun. 30, 2017 Sequential Year-on-year Revenue $8,303 $7,829 $7,462 6% 11% Pretax operating income $1,094 $974 $950 12% 15% Pretax operating margin 13.2% 12.4% 12.7% 75 bps 45 bps Net income - GAAP basis $430 $525 $(74) -18% n/m Net income, excluding charges & credits* $594 $525 $488 13% 22% Diluted EPS - GAAP basis $0.31 $0.38 $(0.05) -18% n/m Diluted EPS, excluding charges & credits* $0.43 $0.38 $0.35 13% 23% *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, “The second quarter was both busy and exciting for Schlumberger as we completed a number of major milestones in preparation for the broad-based global activity upturn that is now emerging. We delivered solid top-line gro

H.I.G. Capital Announces the Sale of KidsFoundation19.7.2018 22:50Tiedote

H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €21 billion of equity capital under management, announced today that one of its affiliates has entered a definitive agreement to sell the KidsFoundation Group (“KidsFoundation”), the Dutch market leader in childcare services, to Onex Corporation (“Onex”)(TSX:ONEX). Terms were not disclosed. Headquartered in Almere, the Netherlands, KidsFoundation provides high-quality childcare to nearly 30,000 children between the ages of six weeks and 12 years. H.I.G. created KidsFoundation in 2014 through the acquisition of assets from the estate of Estro Group. During H.I.G.’s ownership, the company has developed strongly with significant capital invested by H.I.G. to create a high-quality childcare offering. H.I.G. worked with KidsFoundation management to optimise the footprint of the company by exiting loss-making locations, introduce new IT systems to drive operational improvement and develop an internal M&

SIG Combibloc Group Holdings S.à r.l.: 2018 Second Quarter Results19.7.2018 19:01Tiedote

We are pleased to announce our quarterly conference call to discuss the results of SIG Combibloc Group Holdings S.à r.l. for the second quarter ended June 30, 2018. Date: Monday, July 23, 2018 Time: 15.00 CEST / 14.00 BST / 9.00 EDT The call information will be distributed on our secure site. If you would like access to our call, please contact investor.relations@sig.biz . Regards, SIG Combibloc Group Holdings S.à r.l. View source version on businesswire.com: https://www.businesswire.com/news/home/20180719005634/en/ Contact information SIG Combibloc Group Holdings S.à r.l. Jennifer Gough investor.relations@sig.biz

NEORIS Announces Creation of Innovation Labs Worldwide to Create a Smarter Future19.7.2018 18:32Tiedote

NEORIS, a global digital consulting services company, announced today it is consolidating the most innovative solutions it has developed in different geographies and allocating unprecedented resources to deploy a network of Innovation Labs worldwide. The main objective is to lay the foundation for the continuous development of disruptive solutions for its four core industries: Manufacturing, Financial Services, Healthcare and Telecommunications. Due to its disruptive nature, NEORIS decided that its first Innovation Lab should be housed in the Monterrey Digital Hub, which today is the first-of-its-kind as it is a space where entrepreneurs, companies, universities and investors converge to foster an ecosystem for Digital Transformation. The lab inaugurated in Monterrey, Mexico is the first of a series of Innovation Labs that will open in the different countries that NEORIS operates, and is a space where customers can experience emerging technologies through real-life scenarios. One such

CORRECTING and REPLACING Albar Capital Deploys FlexNOW19.7.2018 18:29Tiedote

Subhead of release should read: Out-of-the-Box Multi-Asset Execution Management System (instead of Easy-to-Install Multi-Asset Execution Management System). The corrected release reads: ALBAR CAPITAL DEPLOYS FLEXNOW Out-of-the-Box Multi-Asset Execution Management System FlexTrade (@FlexTrade) today announced that Albar Capital Ltd., a new hedge fund led by Javier Velazquez (formerly of Millennium Capital Partners LLP), is now trading equities and futures using FlexNOW, FlexTrade’s new execution management system. “The FlexNOW team was instrumental in solving several of our problems,” said Jason Ruder, Trader at Albar Capital. “Not only are they helping us with our compliance requirements, they are also responsive to requests that improve my workflow.” According to Rhyd Lewis, FlexNOW Product Manager, FlexNOW’s quick onboarding and easy installation process was critical for Albar Capital’s launch on 2 July. “We had no problem integrating FlexNOW with Albar’s portfolio and risk managemen

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