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: http://www.businesswire.com/news/home/20160919005276/en/
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).
ABOUT W. L. GORE & ASSOCIATES
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.
Chempetitive Group for W.L. Gore & Associates
Andrea Vuturo, +1-858-457-2436
Om Business Wire
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
The Meet Group Announces Closing of Lovoo Acquisition19.10.2017 20:58 | Pressemelding
The Meet Group, Inc. (NASDAQ: MEET), a public market leader in the mobile meeting space, has completed its acquisition of Lovoo GmbH. The LOVOO app is the most downloaded dating app in Germany, Switzerland, and Austria combined. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171019006572/en/ The Meet Group anticipates this purchase will continue the momentum of its mission to meet the universal need for human connection through innovating, acquiring, and building the largest mobile portfolio of brands for meeting new people. The acquisition is expected to expand The Meet Group’s global footprint, increase the company’s scale and profitability, and diversify its business model by adding expertise in subscription and in-app purchasing. “LOVOO is our third strategic acquisition in the last 12 months, and
Edgewater Networks Announces SD-WAN Optimized for BroadSoft Platforms19.10.2017 20:00 | Pressemelding
Edgewater Networks, Inc., the market leader in Network Edge Orchestration, announces the upcoming availability of its SD-WAN offering targeted for Small to Medium Enterprises, a key market for service providers offering Unified Communications as a Service. Edgewater Networks’ SD-WAN solution is optimized for the BroadSoft BroadWorks® and BroadCloud® platforms and brings the benefits of this technology to the BroadSoft customer base. “As a new component of our Network Edge Orchestration platform, Edgewater Networks SD-WAN service allows BroadSoft customers to offer comprehensive end user service level agreements by ensuring that real-time communications are automatically routed to the best available Internet connection,” said Chris Kolstad, Edgewater Networks’ Vice President of Product Management. “Edgewater Networks’ SD-WAN offers a new revenue stream to service providers with a soluti
Business Wire Receives Type 2 SOC 2 Attestation Engagement Report Related to Security19.10.2017 19:20 | Pressemelding
Business Wire today announced that it has successfully completed a Type 2 SOC 2 examination of its BW Connect and HQ systems. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171019006400/en/ The attestation engagement report, conducted by the independent CPA firm Schellman & Company, LLC, confirms that Business Wire has met the standards established by the American Institute of Certified Public Accountants [AICPA] Trust Services Principles related to security. BW Connect is Business Wire’s proprietary web-based order-entry system; HQ provides web-hosting services for online newsrooms, and investor relations hubs for publicly-traded companies. The examination, conducted during the review period February 1, 2017 through July 31, 2017, focused on Business Wire adherence to the Trust Service Principle/Secu
Pharnext: First-Half 201719.10.2017 17:30 | Pressemelding
Regulatory News: Pharnext SA (FR00111911287 - ALPHA), a biopharmaceutical company pioneering a new approach to the development of innovative drugs based on the combination and repositioning of known drugs, today announced its first-half 2017 financial results. Daniel Cohen, M.D., Ph.D. Co-Founder and CEO said of activity for the first half of 2017: "Activity in the first-half of the year was very dense; we implemented two prominent strategic partnerships with the biotech company Galapagos and the Tasly Group, one of the top ten pharmaceutical companies in China. Our flagship product, PXT3003 for the treatment of Charcot-Marie-Tooth disease type 1A, is nearing the end of Phase 3, which is slated for the second half of 2018. We confirm our target of taking the product to market by 2019." A half-year marked by strategic agreements
Tickets Now on Sale for FEI World Equestrian Games Tryon 2018, North Carolina, USA, on September 11-23, 201819.10.2017 16:58 | Pressemelding
Tickets for the FEI World Equestrian GamesTM Tryon 2018 (WEG) are now on sale to the public online at www.tryon2018.com. With more than 500,000 people expected to attend the 2018 Games, the 12-day spectacle of equestrian champions is one of the biggest events on the global sporting calendar and will be the largest equestrian event in North Carolina’s history. Mark Bellissimo, CEO of host venue Tryon International Equestrian Center (TIEC) in Tryon, NC, USA, said: “Demand from the event is way beyond our expectations and it would not surprise me if this event were to sell out early. We have experienced unprecedented demand, far bigger than we ever anticipated. There is tremendous appetite for this event, so we encourage people to buy now.” Tickets for the WEG include the following options: a standard Day Pass, Individual Event Pass, All Session Discipline Pas
SFL – Third-Quarter 2017 Financial Information19.10.2017 16:30 | Pressemelding
Regulatory News: SFL (Paris:FLY): Rental income: €147.8 million, up 3.3% like-for-like Consolidated revenue by business segment (€000’s) 2017 (9 months) 2016 (9 months)
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom