W. L. Gore & Associates (Gore) has received CE Mark approval allowing the expanded use of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) for treating aortic aneurysms in renal and mesenteric arteries.
This approval permits the stent graft to be used as a bridging device with branched and fenestrated aortic endografts.
A multicentre, retrospective and prospective registry was held to assess VBX Stent Graft’s clinical performance and safety as a bridging stent.
The study involved 259 patients across 14 European medical institutions. The study assessed the clinical safety and performance of the VBX Stent Graft.
According to Gore, the study yielded high patency rates and minimised issues such as endoleaks and reinterventions after one year of treatment in both branched and fenestrated cohorts.
EMBRACE registry coordinating investigator and Spedali Civili Brescia vascular surgery associate professor Luca Bertoglio said: “This is a landmark indication for a stent graft, equipping physicians with an on-label solution for more patients in complex pathologies.”
The VBX Stent Graft, which builds on Gore’s ePTFE stent graft technology, is marketed as the longest available balloon expandable stent graft. Its flexibility ranges across diameters from 5 to 11mm and lengths up to 79mm.
This considerable range allows it to adapt to various complex clinical situations while maintaining precise delivery, said the company.
Gore expects hospitals across Europe to begin implementing this newly indicated device in bEVAR and fEVAR procedures in the upcoming weeks, with an official product launch timed post-summer at major congress gatherings.
Participating centres will continue to monitor patients for up to five years, as per the registry’s design encompassing real-world use data critical for ongoing performance assessments, said the firm.
Gore peripheral business leader Jill Paine said: “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.”
