Bentley has announced the successful first-in-human implanation of its recently CE-certified BeFlared stent graft system, which the company states is the world’s first dedicated bridging stent for fenestrated endovascular aneurysm repair (FEVAR).
The procedure was performed by Stéphan Haulon, vascular surgeon at the Hôpital Marie Lannelongue in Paris, France. A press release notes that all Bentley employees had the opportunity to watch the intervention via a livestream.
Bentley details that during the minimally invasive surgery, Haulon first implanted an aortic endoprosthesis through a small opening in the patient’s femoral artery. Then three BeFlared stents were positioned at the fenestrations of the endograft, ensuring an immediate sealing and maintaining blood flow through the visceral arteries to vital organs. In addition, Haulon implanted one regular BeGraft stent at the fourth fenestration. The operation of the 72-year-old patient suffering from a severe aortic aneurysm ended after less than two hours.
“I am happy to report that the BeFlared met all our expectations regarding ease of use during the intervention, duration and matching the requirements of the patient’s anatomy,” Haulon summarised. “The recent certification of the BeFlared marks a milestone in the endovascular treatment of aortic aneurysms as it allows [us] to shorten procedure times and therefore reduce X-ray exposure to patients and operation staff significantly. This ‘two-in-one’ device creates a new standard for bridging stents in FEVAR procedures. The BeFlared is a gamechanger as it makes these interventions safer, faster and enables better outcomes for the patients. It was a pleasure and an honour for me and my team to be part of this development. I dearly thank all Bentley employees involved in the BeFlared project,” added Haulon, who is one of Bentley’s medical advisors.
“The successful ‘first-in-man’ implantation of the BeFlared confirms our strategy and dedication to develop innovative stents in close cooperation with the endovascular community. In the coming weeks, a group of leading international endovascular specialists will also perform FEVAR procedures with the BeFlared in their centres, sharing further clinical data and practical experience of the various implantations. This is an important phase in the market launch of this groundbreaking bridging stent,” Sebastian Büchert, chief executive officer (CEO) of Bentley, explained. Together with Carmen Panero Delgado, head of research and development (R&D) at Bentley, project lead Atilla Duyar, and further team members, Büchert followed the BeFlared first-in-human implantation in the operating theatre.
Bentley advises that series production of the BeFlared has started and after the official market launch at next year’s Leipzig Interventional Course (LINC 2025; 28–30 January, Leipzig, Germany), it will become commercially available as of 3 February 2025, in line with country-specific market regulations.
