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W. L. Gore & Associates Receives CE Mark for Innovative VBX Stent Graft

In a significant advancement for medical solutions in treating complex vascular diseases, W. L. Gore & Associates, Inc. has announced the receipt of a CE certification for their GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. This newly introduced device features a lower profile and is compatible with 6 French sheaths, enhancing the versatility of treatment options available to medical professionals.

A Step Forward in Medical Technology

This development comes as part of Gore's ongoing commitment to improving healthcare outcomes for patients dealing with challenging vascular conditions. The VBX Stent Graft has been recognized as a critical tool in vascular surgery, enabling effective treatment strategies across diverse patient demographics.

The new design is an evolution of an already popular stent graft system that has proven effective since its initial release in the U.S. market in 2017. With more than 500,000 units implanted globally, the VBX Stent Graft has demonstrated its reliability and efficiency, making it a staple in vascular interventions.

Enhanced Features and Improved Usage

The latest VBX Stent Graft introduces a profile reduction of 1 French across most sizes while maintaining its essential characteristics. This design enhancement is purely a result of improvements made to the delivery system rather than alterations to the stent graft itself. With this advancement, physicians can treat a broader range of patients more effectively, potentially lowering the risk of complications and improving procedural efficiency.

Dr. Michele Antonello, Director of the School of Specialization in Vascular Surgery at the University of Padua, commented on the significance of the new profile. "We are pleased to be among the first to implant the new VBX Stent Graft in Europe. The flexibility and precision it offers will enable me to handle complex cases more efficiently with either a 6 or 7 French stent," he stated.

Clinical Studies Support Effectiveness

Supporting the launch of this updated stent graft, Gore has recently disclosed five-year data from clinical studies that enhance confidence in the product’s performance. The ongoing clinical trial, named (NCT05811364), is evaluating the superiority of the VBX Stent Graft compared to traditional bare-metal stents in treating complex iliac occlusive disease.

Dr. Ash Patel, a vascular surgeon at Guy's St Thomas' Hospital NHS Foundation Trust in London, has shared his enthusiasm regarding the profile's benefits. He stated, "This innovation provides an additional reason to trust the proven results of the VBX Stent Graft, making it applicable in various clinical situations."

Future Availability and Continual Commitment

The CE mark signifies that the VBX Stent Graft meets substantial safety and effectiveness standards set by European regulations, with plans to introduce the product to the European market soon. Jill Paine, the head of Gore's Peripheral Business Unit, highlighted the significance of this launch as part of the company’s broader strategy for innovation in collaboration with healthcare professionals.

As Gore continues its mission to develop medical products that address critical health challenges, this innovation represents a promising direction. With over 50 million medical products implanted globally since its inception, Gore’s legacy is one of continuous improvement and support for healthcare providers.

Conclusion

Overall, the introduction of the new GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis with a lower profile stands as a testament to W. L. Gore's commitment to advancing medical solutions. With the potential for improved outcomes in complex vascular surgeries, this product could significantly benefit healthcare providers and their patients alike. For more information on the VBX Stent Graft, visit goremedical.com.