#Germany #GORE VIABAHN VBX #Putzbrunn

GORE Announces CE Mark Approval for GORE® VIABAHN® VBX Stent Graft

In a significant development for vascular surgery, W. L. Gore & Associates has announced that the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis has received expanded CE mark approval. This groundbreaking advancement establishes the device as the first bridging stent with dual indications for both fenestrated and branched endovascular repairs, specifically aimed at treating aortic aneurysms impacting the renal and mesenteric arteries.

An Innovative Solution

Prof. Luca Bertoglio, an esteemed vascular surgery professor at Spedali Civili Brescia, emphasized the remarkable nature of this approval, describing the dual-indication capability of the stent graft as a pivotal solution for addressing complex patient pathologies.

The clinical study supporting this indication involved 259 patients treated with the VBX stent graft, exploring its efficacy across both branched (bEVAR) and fenestrated (fEVAR) endovascular aneurysm repair cohorts. The results showed promising one-year outcomes in terms of patency rates and freedom from endoleaks, target vessel instability, and need for reinterventions.

Clinical Performance Data

The Embraze and Expand registries played a crucial role in assessing the clinical performance and safety of the VBX Stent Graft. This multicenter, retrospective, and prospective study was conducted across 14 European centers and focused on long-term outcomes, with follow-ups extending up to five years post-procedure. Prof. Mauro Gargiulo, chair of the Metropolitan Unit of Vascular Surgery at IRCCS S. Orsola Hospital, hailed this CE-marked indication as a long-awaited development for bridging stents applicable in fenestrated and branched repairs.

He praised Gore's commitment to conducting thorough clinical research and their recognition of the importance of CE-marking in the endovascular community.

Availability and Market Launch

With this approval, hospitals across Europe are expected to start utilizing the newly indicated VBX Stent Graft in fEVAR and bEVAR procedures soon, with an official market launch planned for after the summer. The introduction of this stent graft promises targeted treatment options, ensuring favorable outcomes in a diverse array of complex cases.

The device, constructed using ePTFE-stent graft technology, offers a wide range of diameters, from 5 to 11mm and lengths from 15 to 79 mm—making it the longest balloon-expandable stent graft available. This flexibility allows for extensive adaptability in clinical applications, accommodating up to 16 mm post-dilation diameters with certain models.

Long-Term Commitment to Clinical Excellence

The commitment of Gore to enhancing clinical capabilities in endovascular treatments is exemplified by their involvement in ongoing studies aimed at improving both product indications and patient outcomes. The real-world application data collected through these rigorous clinical studies further emphasizes Gore’s dedication to advancing medical solutions for cardiovascular conditions.

Jill Paine, Gore’s vascular business leader, stated, “This milestone reflects our long-term collaboration with physicians and our commitment to addressing the clinical challenges of complex aortic repair.”

To learn more about the clinical studies supporting the VBX Stent Graft, you can visit the clinical trials database at clinicaltrials.gov and clinicaltrials.gov. Gore continues to provide innovative medical technologies to improve treatment outcomes, reinforcing a legacy of over 55 million implanted medical devices in 45 years of impactful service.

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