W. L. Gore & Associates (Gore) announces CE Mark approval of an expanded indication for the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) when used as a bridging stent with branched and fenestrated aortic endografts† in the treatment of aortic aneurysms involving the renal and mesenteric arteries.

"This is a landmark indication for a stent graft, equipping physicians with an on-label solution for more patients in complex pathologies," said Prof. Luca Bertoglio, Associate Professor, Vascular Surgery, Spedali Civili Brescia and Coordinating Investigator of the EMBRACE Registry.

A total of 259 patients were enrolled in the study. High rates of patency and freedom from endoleaks, target vessel instability and reinterventions were observed with the VBX Stent Graft in both branched and fenestrated EVAR (bEVAR and fEVAR) cohorts at 1 year.

"We have studied performance in both fenestrated and branched cohorts, and the results demonstrate that we can safely and effectively treat these patients with the VBX Device," Prof. Bertoglio added.

This multicenter, retrospective and prospective registry was conducted to evaluate the clinical performance and safety of the VBX Stent Graft as a bridging stent. A total of 14 centers in Europe enrolled 259 patients who have had treatment with the VBX Stent Graft. These subjects will have prospective follow-up visits up to 5 years after the index procedure.

"Physicians have waited some time for an approved bridging stent indication for fenestrated and branched repair. Having a CE-marked indication is very important, as it is certainly of relevance to the endovascular community and the eligible patient population," said Prof. Mauro Gargiulo, Chair of Metropolitan Unit of Vascular Surgery at IRCCS S. Orsola Hospital, University of Bologna and Principal Investigator of the EXPAND1 Registry. "I applaud Gore for recognizing the need for a CE Mark indication and for being committed to conducting such thorough and expertly run clinical studies like EXPAND and EMBRACE."

In the coming weeks, hospitals will start implanting the newly indicated VBX Stent Graft in fEVAR and bEVAR procedures. The official launch is planned after summer when many European and local congresses are taking place. The VBX Stent Graft offers precise delivery and supports positive outcomes in a variety of complex 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. It is currently the longest balloon expandable stent graft available, covering 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 of up to 16 mm with 8L or 11 mm devices.†,2-5

 

Source: prnewswire.com

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