Business Wire

First Implant Completed in Pivotal Study of GORE® TAG® Thoracic Branch Endoprosthesis


W. L. Gore & Associates, Inc. (Gore) today announced the first implant of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE) in the pivotal study. The patient was enrolled by Himanshu Patel, MD, section head of adult cardiac surgery at the University of Michigan Frankel Cardiovascular Center and co-national principal investigator.

This Smart News Release features multimedia. View the full release here:

GORE® TAG® Thoracic Branch Endoprosthesis (Graphic: Business Wire)

GORE® TAG® Thoracic Branch Endoprosthesis (Graphic: Business Wire)

The objective of the study is to determine the safety and efficacy of the TBE in treating lesions of the aortic arch and descending thoracic aorta which includes dissection, trauma, or aneurysm. This pivotal study follows both an early feasibility study conducted in Zones 0-1 with the branch device in the brachiocephalic (BCA) or left common carotid (LCC) arteries and a feasibility study in Zone 2 with the branch device in the left subclavian artery (LSA). The pivotal study will include up to 40 sites across the U.S. that are expected to recruit up to 435 patients, treating all etiologies requiring proximal graft placement in Zones 0-2.

"As a commercially available device, the TBE would offer new less-invasive treatment options for patients with aortic arch disease, which has traditionally challenged both open surgical and endovascular management,” Dr. Patel said. “The conformability of the GORE® TAG® Device combined with the unique side branch design provides a less-invasive treatment of the aortic arch with opportunities for perfusion of the brachiocephalic, left common carotid, or left subclavian arteries."

Aortic arch disease has traditionally been difficult to treat. The options currently available for the treatment of these pathologies require complex procedures such as open surgery, a hybrid approach with surgical re-vascularization, or combination procedures that use devices in an off-label capacity. The limited options for these patients is one of the reasons that the TBE is the first Gore device to receive the new FDA Expedited Access Pathway (EAP) designation and among the first medical devices to receive this designation in the U.S. This pathway is limited to certain medical devices that demonstrate the potential to address unmet medical needs for life-threatening diseases and offer a meaningful patient benefit compared to existing alternatives.

“Based on the success in the feasibility and early feasibility studies, we are excited about this significant next step to treat a broader range of patients with this innovative device,” said Michael Dake, MD, Stanford and co-national principal investigator.

Designed for long-term durability, the GORE TAG Thoracic Branch Endoprosthesis is the first off-the-shelf aortic branch device to participate in a pivotal study. With both an aortic and a side branch component engineered to provide perfusion to one arch vessel, the pre-cannulated device was designed to minimize the risk of branch vessel coverage and improve ease of implantation. The branch component also features Gore's CBAS Heparin Surface, the proven, lasting heparin bonding technology designed to resist thrombus formation.

“The first implant of the TBE in the pivotal study is the latest step in our continuing efforts to offer the broadest endovascular treatment capabilities on the market,” said Ryan Takeuchi, Aortic Business Leader at Gore. “Following a legacy of “firsts” for this device family, we are now the first to advance this therapy into the pivotal phase, allowing the treatment of challenging aortic arch pathologies with an off-the-shelf endovascular device."

The TBE 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 first FDA approved off-the-shelf iliac branch device, the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE), indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. To round out the branched portfolio, studies are ongoing in the U.S. and Brazil for the GORE® EXCLUDER® Thoracoabdominal Branch Device (TAMBE).

At Gore, we have provided creative therapeutic solutions to complex medical problems for 40 years. During that time, 40 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. Our extensive family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery. We are one of a select few companies to appear on all of the U.S. “100 Best Companies to Work For” lists since the rankings debuted in 1984.

Products listed may not be available in all markets.
CBAS is a trademark of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc.
GORE®, EXCLUDER®, TAG®, and designs are trademarks of W. L. Gore & Associates.

Contact information

Chempetitive Group for W.L. Gore & Associates
Andrea Vuturo, +1-858-457-2436

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(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

Summer Business with New Shop Feature and High-Performance Tyre Models16.3.2018 14:11Pressemelding

Each year, summer trade means great challenges for car garages and tyre dealers. As a result and at just the right time,, the online trade customer shop by Europe’s leading online tyre dealer Delticom, is introducing a new feature intended to make the daily work of the shop’s customers easier: An advice mode is available from now on at When changing from the purchasing to the sales view, the individual end customer prices are displayed instead of the actual purchase prices. In order to use this feature, users of simply have to insert their individual markups for the different item groups. From the markup and the purchase price, the online shop automatically calculates the personal end customer price. The usual purchasing view is also still available. This press release features multimedia. View the full release here: An advice mode immediately helps trade customers use the full pot

Available Now: The Smartphone Made for the Way We Communicate Today, the Galaxy S9 and S9+16.3.2018 12:00Pressemelding

Samsung Electronics America, Inc. announced that the new, award-winning Galaxy S9 and Galaxy S9+, which have been recognized by smartphone reviewers worldwide for their best-in-class display, design and camera, are now available for purchase at U.S. wireless network providers and retail stores. The phones come in three colors: Midnight Black, Coral Blue, and the new Lilac Purple. The Galaxy S9 has a suggested retail price of $719.99, while the Galaxy S9+ is available for $839.99. Both unlocked and carrier versions of the Galaxy S9 and Galaxy S9+ are also available for purchase on This press release features multimedia. View the full release here: Designed for the way we communicate today, Samsung's new Galaxy S9 and Galaxy S9+ are available in the U.S. at wireless network providers, retailers and on (Photo: Business Wire) “The Galaxy S9 and S9+ are designed for the visual and social generation—the consum

CONQUEST Group Announced the Expansion of its Asset Management Business with the Appointment of Philippe Taillardat to the Role of Director16.3.2018 09:00Pressemelding

Philippe Taillardat brings to CONQUEST over 25 years of Asset Management and Investment Banking experience, primarily in principal investing, financial advisory, equity and debt financing across global infrastructure and sustainable energy sectors. This press release features multimedia. View the full release here: Philippe Taillardat (Photo: CONQUEST Group) Philippe was most recently Co-Head of Infrastructure Investments Europe at First State Investments, which he helped transform into one of the leading billion+ European infrastructure fund manager in core / core+ strategies. Earlier in his career, Philippe held various senior banker and investment roles at Amundi, Credit Agricole CIB, Credit Suisse, AXA and BNP Paribas. Frédéric Palanque, Managing Director of CONQUEST Group, said, "We are delighted to welcome such a recognized professional. CONQUEST is trusted for providing value-added advice in complex and highly confidential

AccelStor All-Flash Solutions Unlock Data Possibilities for AI and Cloud16.3.2018 09:00Pressemelding

AccelStor, an innovative all-flash array (AFA) provider for the big data era, is excited to announce its participation in the upcoming Cloud Expo Europe, taking place from March 21 to 22 at Booth C1850 in the ExCel London exhibition centre. Besides presenting latest all-flash storage solutions breaking through performance and availability barriers for artificial intelligence (AI), virtualization and private cloud, AccelStor will present a live demonstration of its new generation NeoSapphire high availability models, one of the highlights not to be missed this year. This press release features multimedia. View the full release here: AccelStor's new generation NeoSapphire High Availability all-flash array AccelStor NeoSapphire all-flash arrays are highly integrated with virtualization and private cloud platforms, supporting VMware vSphere and OpenStack Cinder. NeoSapphire’s “high availability” series features symmetric active-activ

Westinghouse Completes First Major Decommissioning Work at a Nordic Commercial Nuclear Reactor16.3.2018 08:45Pressemelding

Westinghouse Electric Company announced today that it has completed a major decommissioning project at the former Barsebäck nuclear power plant in Skåne, Sweden. Barsebäck Unit 2 ceased operation in 2005 and decommissioning work began in August 2016. Westinghouse’s scope of work included the underwater segmentation and packaging of the reactor vessel internals, as well as the upfront engineering studies and equipment manufacturing and qualification. “Westinghouse is proud to deliver this major decommissioning project on time and on budget,” said Yves Brachet, Westinghouse senior vice president, Global Decommissioning, Decontamination, Remediation and Waste Management. “Our global expertise in this area will help our customers in the Nordic region to safely manage a variety of end-of-life opportunities for commercial nuclear power plants.” Leadership at Barsebäck Kraft AB (BKAB) is equally satisfied with this successful initial step of the first dismantling of a commercial nuclear power

Lighting Manufacturer LTS Licht & Leuchten, Part of the Fargerhult Group, to Offer Selected Spot- & Downlights with Seoul Semiconductor’s SunLike Series Natural Spectrum LEDs16.3.2018 08:02Pressemelding

Seoul Semiconductor, a global innovator of LED products and technology, announced that its SunLike Series natural spectrum LEDs, which implement light closest to the spectrum of natural sunlight, has been adopted for selected luminaires of LTS Licht & Leuchten GmbH, a German manufacturer of high-quality luminaires for hospitality, retail, and office applications. This press release features multimedia. View the full release here: LTS Jett 100 spotlights equipped with SunLike LED technology (Photo: Business Wire) LTS has adopted SunLike natural spectrum LEDs for selected products, including the Jett 100 and CSA 60 spotlights. A series of spotlights with a discreet and individual appearance, and clear, straightforward design lines, Jett spotlights harmoniously blend in with any type of retail application. The high color rendering and superior luminous intensity of these spotlights enable lighting designers to achieve accentuated ar