GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Receives Expanded Indication for Bridging Stents

Expansion of Indication for the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

W. L. Gore & Associates, renowned for their advanced medical devices, has made a significant announcement regarding the approval of an expanded indication for the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft). This device is now recognized for its use as a bridging stent in both branched and fenestrated endovascular aortic repair (EVAR), marking a major advancement in the treatment of aortic aneurysms, particularly those affecting the renal and mesenteric arteries.

A Landmark Achievement

The approval of this expanded indication has been a pivotal moment for practitioners treating complex aortic conditions. Professor Luca Bertoglio, an Associate Professor of Vascular Surgery and a leading researcher in this field, emphasized the significance of this new approval. He stated that the VBX Stent Graft now provides an on-label solution for a broader range of patients suffering from intricate vascular pathologies, thus enhancing the treatment landscape.

The expanded indication was based on robust clinical data collected from a multicenter registry that included 259 patients. Findings showcased high rates of success in terms of patency, with minimal occurrences of endoleaks, vessel instability, and the need for reinterventions one year following the procedure. This reinforced the confidence in the VBX Stent Graft as a viable option for clinicians dealing with challenging aortic repairs.

Comprehensive Clinical Evaluation

This study combined both retrospective and prospective data, further validating the safety and efficacy of the VBX Stent Graft. 14 European centers participated in this initiative, demonstrating a strong collaborative effort to enhance patient outcomes in vascular surgery. Continuous monitoring of these patients will take place for up to five years, ensuring that long-term effectiveness and safety profiles are thoroughly assessed.

Professor Mauro Gargiulo, who leads the Metrovascular Surgery Unit at the University of Bologna, remarked on the long-awaited nature of this approved bridging stent. He highlighted how vital it is for the endovascular community and for patients who depend on these complex repairs to have CE-marked solutions available.

Future Implications for Healthcare Providers

The introduction of the VBX Stent Graft is poised to commence in hospitals shortly, particularly in procedures involving fenestrated and branched endografts (fEVAR and bEVAR). As clinician confidence grows, the device is expected to significantly improve treatment outcomes for these patients as indicated. Importantly, the VBX Stent Graft is developed with small-diameter ePTFE stent graft technology, allowing for precise delivery and improved performance in various complex applications.

Available in a spectrum of diameters from 5 to 11 mm and lengths up to 79 mm, the VBX Stent Graft is recognized as the longest balloon expandable stent graft available on the market today. Its ability to adjust diameters up to 16 mm in a single device epitomizes innovation in medical device engineering, meeting a broad range of treatment needs.

Continuous Innovation and Research Commitment

Gore’s mission extends beyond merely providing devices; it encompasses a broader commitment to advancing medical science and improving patient outcomes through ongoing research. The EMBRACE and EXPAND registries are a testament to this dedication, reflecting Gore's ongoing efforts to gather real-world data that inform device performance and clinical practice.

The company's leadership in evolving endovascular treatment capabilities is underscored by years of collaborative efforts with clinicians, striving to address the complex challenges associated with aortic repairs. Jill Paine, who leads Gore's Peripheral Business, emphasized that this progress represents a culmination of sustained cooperation aimed at advancing healthcare solutions.

In conclusion, the CE Mark approval is not just a regulatory milestone but a beacon of hope for numerous patients worldwide dealing with significant vascular issues. As Gore prepares for the official launch post-summer, the medical community eagerly anticipates the impact of this enhanced device on patient care. For more detailed information on the GORE® VIABAHN® VBX Stent Graft, interested parties can visit goremedical.com/eu.