Gore’s Viabahn VBX Balloon Expandable Endoprosthesis to Be Studied as a Bridging Stent in EMBRACE Registry

February 21, 2023—Gore & Associates announced the initiation of the EMBRACE Registry, which is being conducted to capture real-world data on Gore’s Viabahn VBX balloon expandable endoprosthesis (VBX stent graft) used as a bridging stent in conjunction with a branched/fenestrated stent graft in the treatment of aortic aneurysms involving the renal-mesenteric arteries.

According to the company, EMBRACE is a retrospective and prospective registry that will evaluate the clinical performance and safety of the VBX stent graft as a bridging stent.

The registry will be composed of a minimum of 220 patients who will be enrolled at up to 15 centers in Europe. Patients will have been treated with the VBX stent graft and will have prospective follow-up visits up to 5 years from the initial procedure.

Gore stated that the study’s primary efficacy endpoint will be target vessel patency at 12 months. 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. The 1-year results of the registry are expected in mid-2023 and are intended to be published and presented at major congresses.

Professor Luca Bertoglio, MD, who is Associate Professor, Vascular Surgery, at Spedali Civili Brescia in Brescia, Italy, serves as coordinating investigator of the registry.

“Currently, all stents are used off-label during fenestrated and branched endovascular procedures,” commented Prof. Bertoglio in Gore’s press release. “This study will evaluate the VBX stent graft clinical performance and eventually support device indication expansion for on-label use.”

Prof. Bertoglio continued, “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.”

Gore advised that the VBX stent graft is available in diameters of 5 to 11 mm and lengths of 15, 19, 29, 39, 59, and 79 mm, to cover a wide variety of treatment needs.

The VBX stent graft was designed to provide precise delivery and positive outcomes in complex aortoiliac applications. The device was developed utilizing the small-diameter expanded polytetrafluoroethylene stent graft technology from the Viabahn endoprosthesis.

The EMBRACE registry is part of Gore’s effort to expand device indications and improve clinical practice and patient outcomes by assessing device performance in real-world clinical use combined with data from long-term clinical investigations and reports from medical literature, stated the company.

The Viabahn VBX device was introduced in Europe in December 2017. In the United States, it received FDA approval in January 2017.