The EMBRACE Registry aims to evaluate 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 (16 February, 2023) — W. L. Gore & Associates, Inc. (Gore) announced that it is initiating the EMBRACE Registry to capture real-world data about the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) used as a bridging stent in conjunction with a branched/fenestrated stent graft.
This multicenter, retrospective registry is being conducted to evaluate the clinical performance and safety of the VBX Stent Graft as a bridging stent, an investigational indication. Up to 15 sites in Europe will be required to enroll a minimum of 220 patients that have had treatment with the VBX Stent Graft. These subjects will have prospective follow-up visits up to five years from the initial procedure.
The primary efficacy endpoint will be the target vessel patency at 12 months. Other secondary endpoints will address technical success, reinterventions and target vessel instability from a performance perspective, and aneurysm-related mortality and Major Adverse Events from a safety perspective. One-year results of the registry are expected mid-2023 and results are intended to be published and presented at major congresses thereafter.
“Currently, all stents are used off-label during fenestrated and branched endovascular procedures. This study will evaluate the VBX Stent Graft clinical performance and eventually support device indication expansion for on-label-use,” said Prof. Luca Bertoglio, Associate Professor, Vascular Surgery, Spedali Civili Brescia and Coordinating Investigator of the registry. “The EMBRACE Registry will track the real-world effectiveness and safety of the device, 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 delivery and supports positive outcomes in complex aortoiliac applications. The device was developed utilizing the small diameter, ePTFE stent graft technology from the GORE® VIABAHN® Endoprosthesis. The VBX Stent Graft is available in a range of diameters from 5 to 11 mm and lengths of 15, 19, 29, 39, 59 and also 79 mm, 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 adjustability in a single device, with a maximum post-dilated diameter up to 16 mm with 8L or 11 mm devices.
Additional information about the clinical study is available at: www.clinicaltrials.gov
EMBRACE is part of Gore’s dedication to research, fitness-for-use and long-term device performance in an effort to expand device indications, improve clinical practice and patient outcomes. Data will be representative of real-world, clinical use. Real-world, clinical-use data are integral for Gore, combined with data from long-term clinical investigations and reports from medical literature, to perform continuing assessments of device performance in addition to any long-term clinical investigations as well as reports in medical journals and congress presentations.
“Long-term durability and patient outcomes are the cornerstone of our research and development,” said Francisco Barquero, Gore EMEA Peripheral Sales Leader. “This is another step in our continuing efforts to offer the broadest endovascular treatment capabilities on the market.”
For more information about the VBX Stent Graft, visit: goremedical.com/eu/products/vbx
Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 50 million medical devices implanted over the course of more than 45 years, Gore builds on its legacy of improving patient outcomes 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 is joined in service with clinicians and through this collaboration we are improving lives.
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world’s highest peaks to the inner workings of the human body. With more than 12,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $4.5 billion.
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