W. L. GORE & ASSOCIATES, INC. RECEIVES CE MARK FOR LOWER PROFILE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS, NOW 6 FR SHEATH COMPATIBLE
With improvements to the stent graft delivery system enabling a 1 Fr profile reduction on the majority of sizes, the device continues to offer physicians the broadest offering of diameters and lengths available on the market.1-5
PUTZBRUNN, Germany, Jan. 13, 2025 /PRNewswire/ -- As part of efforts to continuously improve medical solutions for patients with complex vascular disease, W. L. Gore & Associates, Inc. Medical Products (Gore) announced recent CE mark of a lower profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft).
Medical Device Regulation (MDR) approval of this innovation builds on a proven device which has become an important tool for treating complex vascular disease.* In addition to offering the longest balloon expandable stent on the market with its 79 mm configuration, and the widest range of stent diameter adjustability, the VBX Stent Graft now also offers the most 6 Fr compatible configurations.1–5
"We are thankful to Gore for being able to be one of the first implanters of the new lower profile VBX Stent Graft in Europe", said Prof. Michele Antonello, Director of the School of Specialization in Vascular Surgery of the University of Padua. "Combined with the device flexibility, its accuracy and trusted performance, the new lower profile will enable me to treat my complex cases with a 6 or 7 Fr device."
No changes to the stent graft design were made to achieve the lower profile. By focusing on improvements to the delivery system only, the valued characteristics and trusted performance of the stent graft itself remain unchanged and are joined by the enhanced versatility a lower profile provides. Depending on the practice, physicians may be able to use the VBX Stent Graft with a broader set of patients, experience a lower risk of complications at the access site, find improved procedure efficiency and/or a general improvement in ease of use.
"With the recently published 5-year data† and being part of the current Gore VBX FORWARD Clinical Study (NCT05811364) that aims to investigate the superiority of the VBX Stent Graft compared with bare metal stents for the treatment of complex iliac occlusive disease, this lower profile innovation provides yet another reason to feel confident in the proven outcomes of the VBX Stent Graft and the broad applicability of its use in my practice", said Ash Patel, M.D., Vascular Surgeon, Guy's & St Thomas' Hospital NHS Foundation Trust, London, U.K.
Since its U.S. launch in 2017, more than 500,000 VBX Stent Grafts have been implanted worldwide.‡ The VBX Stent Graft is indicated in the EU for the treatment of: De novo or restenotic lesions in the iliac arteries, including lesions at the aortic bifurcation; De novo or restenotic lesions in the visceral arteries; Isolated visceral, iliac and subclavian artery aneurysms; or Traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral and pulmonary arteries).
The lower profile device will be rolled out to the European market over the coming months.
"The approval and release of the lower profile VBX Stent Graft serves as a demonstration of the Gore Medical Products Division's commitment to continual improvement and lifelong innovation in collaboration with physicians to solve tough challenges where there is a critical patient need," said Jill Paine, Leader of Gore's Peripheral Business. "We look forward to supporting our physicians and their patients through the delivery of this exciting innovation to their treatment toolbox."
For more information about the lower profile VBX Stent Graft visit: goremedical.com/eu/products/vbx
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. For more information, visit goremedical.com.
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 $4.8 billion.
For more information, visit gore.com.
For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).
* Complex defined as TASC II classification C & D lesions.
† Recently 5-year data have been published for VBX, and an ongoing assessment for similar data for the reduced profile is underway.
‡ Data on file 2024; W. L. Gore & Associates, Inc.; Flagstaff, AZ.
1. Gore Medical Products Instructions for Use (IFU). W. L. Gore & Associates, Inc. Accessed September 10, 2024. https://eifu.goremedical.com/
2. BeGraft Peripheral Plus Stent Graft System [Instructions for Use]. Hechingen,Germany: Bentley InnoMed GmbH. BeGraft Peripheral Stent Graft System [Instructions for Use]. Hechingen, Germany: Bentley InnoMed GmbH.
3. BD® LIFESTREAM® Balloon Expandable Vascular Covered Stent [Instructions for Use]. Tempe, AZ: Bard Peripheral Vascular, Inc; 2016. PK1345700 Rev. 4 07/16.
4. Advanta V12 balloon expandable Covered Stent [Instructions for Use]. Merrimack, NH; Atrium Medical Corporation.
5. iCover Peripheral balloon expandable PTFE covered stent system [Instructions for Use]. Barcelona, Spain. iVascular S.L.U.
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