Gore previously received approval from the U.S. Food & Drug Administration (FDA) for the enhanced GORE VIABAHN Endoprosthesis. This approval builds on a market-leading device with more on-label applications than any other self-expanding stent graft,* which has become an important tool for treating complex vascular disease.
"With broad clinical indications for use and numerous product improvements, the VIABAHN Device continues to be a dependable choice that demonstrates positive results in patients with complex vascular disease," said Amit J. Dwivedi, M.D., Associate Professor of Surgery and Chief of the Division of Vascular Surgery and Endovascular Therapeutics at the University of Louisville, who has implanted the lower profile device in complex arterial anatomy. "Older patients with co-morbidities such as hypertension, diabetes and obesity may benefit from a less invasive endoluminal approach versus surgical bypass. These latest enhancements, including a lower profile, provide physicians with additional options for treating these patients."
This innovative VIABAHN Device design reduces the delivery profile for larger 9–13 mm diameter stent grafts by up to 3 Fr, enabling delivery through smaller sheaths. Smaller introducer sheaths have resulted in a lower risk of vascular access complications in select patient populations.1 Additionally, new radiopaque markers on the distal and proximal ends enhance visualization under fluoroscopy, facilitating positioning and device delivery, as well as precise and predictable placement.
"In addition to the radiopaque markers that facilitate positioning and deployment, the new lower profile enables use of a smaller sheath, potentially reducing the risk of damage at the access site," said Yevgeniy (Eugene) Rits, M.D., Chief and Program Director of Vascular Surgery at Wayne State University and Detroit Medical Center and Director of the Dialysis Access Center and Vascular Lab at Harper University Hospital. "Combined with the trackability and flexibility I've always trusted with VIABAHN Devices, this new lower profile offering will become very instrumental in my dialysis access practice."
"The story of the GORE VIABAHN Endoprosthesis is a story of physician collaboration across four patient-centric indications, and of proving performance over and over," said Benjamin Beckstead, Gore Vascular Category Leader. "And it is a story of teamwork, continual improvement and lifelong innovation that continues today: partnering with physicians to solve tough challenges where there is a critical patient need, driven by our relentless inspiration to innovate today through a purposeful approach to developing solutions for tomorrow."
Since its U.S. launch in 2002, the device has evolved with numerous enhancements and supported hundreds of thousands of patients worldwide. Currently, the VIABAHN Device is indicated for use in superficial femoral artery (SFA) lesions, iliac lesions, in-stent restenosis of SFA lesions and in stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous access grafts for hemodialysis.† For more information, visit https://www.goremedical.com/products/viabahn
*Based on Millennium Research Group, Inc. data, reflecting unit and revenue share.
†For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).
1. Applegate RJ, Sacrinty MT, Kutcher MA, et al. Trends in vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention via the femoral artery, 1998 to 2007. JACC: Cardiovascular Interventions 2008;1(3):317-326.
Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 50 million medical devices implanted over the course of more than 45 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
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world's highest peaks to the inner workings of the human body. With more than 10,500 Associates and a strong, team-oriented culture, Gore generates annual revenues of $3.7 billion.
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GORE, Together, improving life, VIABAHN and designs are trademarks of W. L. Gore & Associates. AY0842-EN1 SEPTEMBER 2020