#USA #Flagstaff #GORE VIABAHN VBX

W. L. Gore & Associates Receives CE Mark for VBX Endoprosthesis

W. L. Gore & Associates, Inc. has recently announced the receipt of the CE mark for its innovative GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. This new device, designed with a lower profile, is now compatible with a 6 Fr sheath. This move signifies a significant leap forward in the treatment options available for patients suffering from complex vascular diseases.

Continuous Improvement in Medical Solutions

The GORE® VIABAHN® VBX represents Gore's commitment to continually improving outcomes in the medical landscape. The company has a history of focusing on the intersection of advanced materials science and healthcare, and this latest innovation is no exception. The lower profile design enhances the device’s usability without compromising its integrity or effectiveness. Physicians are now able to deploy the endoprothesis with enhanced flexibility and precision, making it a valuable tool in vascular surgery.

Professor Michele Antonello, Director of the Vascular Surgery Residency Program at the University of Padua, expressed gratitude for being one of the early adopters of this groundbreaking product in Europe. The expanded capabilities of the VBX, paired with its established performance metrics and versatility, provide medical professionals with greater options for treating challenging cases.

Expanded Compatibility and Performance

The CE marking approval is anchored in decades of proven efficacy. Gore has altered the design to optimize the deployment system, allowing a reduction of 1 Fr in the profile across most sizes, while still offering a wide range of diameters and lengths for the device. This technological enhancement is a direct response to the varying needs of vascular disease patients and a continuing trend towards minimizing procedural risks.

Moreover, the endoprothesis is the longest balloon-expandable option available on the market today, with configurations reaching up to 79 mm. The extended compatibility with a 6 Fr sheath allows physicians to broaden the range of patients they can treat effectively.

The innovative characteristics do not alter the established, trusted design of the endoprothesis itself. Given the array of benefits, these advancements could lead to reduced complication rates, increased procedural efficiency, and better overall patient outcomes.

Clinical Insights and Clinical Trials

The conversation surrounding the VBX is further buoyed by the recently published five-year data from an ongoing clinical study. Dr. Ash Patel, a vascular surgeon at Guy's and St Thomas' Hospital NHS Foundation Trust in London, highlighted the importance of this clinical trial in establishing the superiority of the VBX over traditional metallic endoprotheses for treating complex occlusions.

With more than 500,000 VBX stents implanted globally since its U.S. debut in 2017, the product is already making significant impacts in patient care. In the European Union, indications for using the VBX include various arterial lesions, isolated aneurysms, and traumatic injuries affecting specific vascular sites (excluding areas like the aorta and coronary arteries).

Jill Paine, Head of the Peripheral Division at Gore, articulated the company's commitment to innovation and collaboration with the medical community. The VBX endoprothesis’s recent approval stands as a testament to Gore’s relentless pursuit of enhancing therapeutic tools that address pressing health challenges.

Looking Ahead

The GORE® VIABAHN® VBX endoprothesis is set for an official market launch in Europe in the coming months. As it becomes available, both physicians and patients can expect a significant improvement in the management of complex vascular conditions.

For more detailed information on the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis and how it could fit into clinical practices, please visit goremedical.com/eu/products/vbx.

Gore’s longstanding history of product excellence serves to reinforce its mission — improving patient quality of life through continuous innovation in medical technology. With a solid foundation built over more than 45 years of experience and more than 55 million devices implanted worldwide, Gore remains dedicated to overcoming complex medical challenges with cutting-edge solutions.