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Gore Initiates Study to Evaluate GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent
The purpose of the EMBRACE Registry is to evaluate the safety and performance of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a bridging stent with branched and fenestrated endografts in the treatment of aortic aneurysms involving the renal-mesenteric arteries.
PUTZBRUNN, Germany, February 16, 2023 /PRNewswire/ -- W. L. Gore
This retrospective and prospective multicenter registry is underway to evaluate the clinical performance and safety of the VBX stent-graft as a bridging stent-graft. Up to 15 centers in Europe will be needed to enroll a minimum of 220 patients who have received treatment with the VBX stent-graft. These subjects will have prospective follow-up visits up to five years after the initial procedure.
The primary efficacy endpoint will be target vessel patency at 12 months. Other secondary endpoints will address technical success, reoperations, and target vessel instability from a performance standpoint, and aneurysm-related mortality and serious adverse events from a safety standpoint. The results of the registry after one year are expected by mid-2023, and will subsequently be published and presented at major conferences.
"Currently, all stents are used off-label in fenestrated and branching endovascular procedures. This study will evaluate the clinical performance of the VBX stent-graft and, over time, will support the expansion of the device's indication for use in the label," said Prof. Luca Bertoglio, Associate Professor of Vascular Surgery, Spedali Civili Brescia and Coordinating Investigator of the registry. "The EMBRACE Registry will track the efficacy and safety of the device in the real world, with minimal inclusion and exclusion criteria, and I look forward to the results and seeing the long-term value of this device."
The VBX Stent Graft offers precise placement and enables positive results in complex aortoiliac applications. The device was developed using the small diameter ePTFE-coated stent technology of the GORE® VIABAHN® Endoprosthesis. The VBX stent graft is available in a range of diameters from 5 to 11mm and lengths of 15, 19, 29, 39, 59 and also 79mm, currently the longest balloon expandable stent graft available, to cover a wide variety of treatment needs. The VBX Stent Graft also offers the largest range of diameter adjustment in a single device, with a maximum post-dilatation diameter of up to 16mm with 8L or 11mm devices.
More information about the clinical trial at: www.clinicaltrials.gov
EMBRACE is part of Gore's dedication to device research, fitness for use, and long-term performance in an effort to expand device indications, improve clinical practice, and improve patient outcomes. Data will be representative of real-world clinical use. Data from real-world clinical use is essential for Gore, combined with data from long-term clinical investigations and reports from the medical literature, to conduct ongoing evaluations of device performance in addition to any long-term clinical investigations and reports. in medical journals and conference presentations.
"Long-term durability and patient outcomes are the cornerstone of our research and development," said Francisco Barquero, Gore EMEA Head of Peripherals Sales. "This is another step in our continued efforts to offer the broadest endovascular treatment capabilities on the market."
For more information on the VBX Stent Graft visit: goremedical.com/eu/products/vbx
Gore designs devices that treat a number of cardiovascular and other health conditions. With more than 50 million medical devices implanted over more than 45 years, Gore builds on its legacy of improving conditions for patients through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore has merged its services with medical services; thanks to this collaboration we are improving lives.
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