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07.08.2025 - 18:00:30

GORE ANNOUNCES MDR EXPANDED INDICATION FOR THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS AS A BRIDGING STENT. L.

and https://clinicaltrials.gov/study/NCT03720704

EMBRACE and EXPAND Registries are part of Gore's dedication to research, fitness-for-use and long-term device performance in an effort to expand device indications, improve clinical practice and patient outcomes. Data will be representative of real-world, clinical use. Real-world clinical use data are integral for Gore, combined with data from long-term clinical investigations and reports from medical literature, to perform continuing assessments of device performance in addition to any long-term clinical investigations as well as reports in medical journals and congress presentations.

"This is another step in our continuing efforts to offer the broadest endovascular treatment capabilities on the market. This announcement is the culmination of years of deep collaboration with physicians aimed at understanding and overcoming clinical and technical challenges in complex aortic repair," according to Jill Paine, leader of Gore's Peripheral Business.

For more information about the VBX Stent Graft, visit goremedical.com/eu.

Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 55 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.

goremedical.com/eu.

About Gore

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 13,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $5 billion.

gore.com.

Indication applicable to GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. New evaluation of reduced profile delivery is underway.

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For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).

Gore completes enrollment in the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis EXPAND Registry Press Release. Gore Medical Products website. Accessed March 20, 2025. https://www.goremedical.com/eu/news/expand-registry-enrollment-gore-vbx-2022-10

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BD® LIFESTREAM® Balloon Expandable Vascular Covered Stent [Instructions for Use]. Tempe, AZ: Bard Peripheral Vascular, Inc; 2016. PK1345700 Rev. 4 07/16.

Advanta V12 balloon expandable Covered Stent [Instructions for Use]. Merrimack, NH; Atrium Medical Corporation.

iCover Peripheral balloon expandable PTFE covered stent system [Instructions for Use]. Barcelona, Spain. iVascular S.L.U.