Gore Expands MDR Indication for GORE® VIABAHN® VBX
In a groundbreaking development for vascular surgery, W. L. Gore & Associates has received CE mark approval for an extended indication of its GORE® VIABAHN® VBX balloon-expandable endoprosthesis. This new designation allows the VBX device to be utilized as a bridge stent in complex endovascular repairs involving fenestrated and branched aortic grafts. This expanded capability marks a significant milestone, enhancing treatment options for patients with challenging vascular conditions, specifically those affecting renal and mesenteric arteries.
The approval was revealed on July 9, 2025, in Putzbrunn, Germany, where the company emphasized that this advancement provides a certified solution to healthcare providers dealing with intricate aortic repairs. Prof. Luca Bertoglio, a prominent vascular surgery professor and the coordinator for the EMBRACE registry, highlighted the historical significance of this indication. It offers an opportunity for medical practitioners to effectively address a broader array of patient needs, bolstering procedural capabilities in the increasingly complex field of endovascular medicine.
The clinical data driving this approval is substantial, stemming from a multi-center study involving 259 patients. The results demonstrated robust effectiveness marked by high patency rates and the absence of endoleaks—a critical concern in endovascular procedures—as well as stability in the target vessel. The VBX stent graft has proven to safely and effectively treat patients in cohorts undergoing branched endovascular aortic repair (bEVAR) and fenestrated endovascular aortic repair (fEVAR).
As part of the EMBRACE registry, which tracked the long-term performance and safety of the VBX graft, researchers have been able to compile a wealth of data to inform clinical practices and improve patient outcomes. In addition, the anticipated rollout of the VBX stent graft across hospitals in Europe is set to begin shortly, with formal presentations and launches planned around numerous upcoming medical conferences.
The GORE® VIABAHN® VBX device stands out as the longest balloon-expandable stent graft currently available, offering diameters from 5 mm to 11 mm and lengths ranging from 15 mm up to 79 mm. Its design incorporates an innovative small-diameter ePTFE stent graft technology, catering to a comprehensive range of therapeutic needs in vascular applications. The VBX also notably features an impressive adjustable diameter that allows for post-dilation up to 16 mm, offering flexibility in various clinical situations.
As stated by Prof. Mauro Gargiulo, a leading vascular surgeon and principal investigator for the EXPAND registry, the long-awaited approval for the bridge stent designation is momentous for the endovascular community. With both the EMBRACE and EXPAND registries, Gore is committed to advancing clinical understanding and facilitating the uptake of new therapeutic options that can significantly improve patient outcomes.
Moreover, Jill Paine, Gore’s Peripheral Business Director, emphasized that this significant step reflects Gore’s continuous efforts to enhance endovascular treatment capabilities. The company has long championed collaboration with clinicians to refine solutions that address complex vascular repair challenges. The approved indication reaffirms Gore’s dedication to extensive clinical research and long-term performance evaluation of its medical devices.
As the medical community prepares for the official launch and initial patient procedures featuring the VBX, there is an air of optimism regarding the potential for improved patient care in vascular medicine. Gore continues to sculpt the landscape of medical innovation with over 55 million devices implanted globally, marking a legacy of research-driven excellence and collaboration.
For further information about the GORE® VIABAHN® VBX stent graft and to stay updated on upcoming clinical findings, visit
goremedical.com/eu.
Conclusion
This recent expansion of MDR indication for the GORE® VIABAHN® VBX illustrates Gore's continuous innovation and commitment to improving patient outcomes in complex vascular surgeries. As hospitals gear up for the upcoming implementations, the stent graft is poised to make a significant impact on deepening treatment capabilities for patients facing intricate vascular challenges.