World premiere for Bentley’s BeFlared Bridging Stent: Successful “First in Man” Operation
Hechingen, November 26th, 2024 -- Shortly after receiving the CE certification for its BeFlared Stent Graft System, the world’s first dedicated bridging stent for fenestrated endovascular aneurysm repair (FEVAR), Bentley announced the successful “first in man” implantation of this product. The procedure was performed by Prof. Stéphan Haulon, vascular surgeon at the Hôpital Marie Lannelongue in Paris. As this marks decisive progress in the company’s strategy to improve clinical outcomes for patients by providing innovative stents for complex endovascular procedures, all Bentley employees had the opportunity to watch the intervention via a livestream.
During the minimally invasive surgery, Prof. Haulon first implanted an aortic endoprosthesis through a small opening in the patient’s femoral artery. Then 3 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, he 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 a total procedure time of 80 minutes only. “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,” Prof. Haulon summarized. “The recent certification of the BeFlared marks a milestone in the endovascular treatment of aortic aneurysms as it allows to shorten procedure times and therefore reduce x-ray exposure to patients and operation staff significantly. This “2 in 1” device creates a new standard for bridging stents in FEVAR procedures. The BeFlared is a game changer as it makes these interventions safer, faster, and enables better outcomes for the patients. It was a pleasure and an honor for me and my team to be part of this development. I dearly thank all Bentley employees involved in the BeFlared project,” added the leading endovascular surgeon from Paris and 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, CEO of Bentley, explained. Together with Carmen Panero Delgado, head of R&D at Bentley, and further team members, he followed the BeFlared “first in man” in the operation theatre at Paris.
At Hechingen, Bentley’s CTO Christian Bader provided further commentary to more than 250 Bentley employees who had gathered in the canteen to watch the procedure that was also broadcasted live to the company’s Swiss site in Frauenfeld, and to its global sales offices. Bentley’s founders Lars Sunnanväder and Miko Obradovic (the latter having initiated the development of the BeFlared) also took the opportunity to witness the successful implantation. When Prof. Haulon ended the implantation of the BeFlared, all cheered enthusiastically. Representative of all employees involved in the BeFlared project, Maja Schuster, member of the Product Testing team, got to the heart of the matter: “We are so excited to see how well the BeFlared performed in practice. We all are really proud to have been part of this. We have been testing numerous stents to ensure optimum design and quality. It was demanding, but worth every effort,” she said.
Series production of the BeFlared has started and after the official market launch at the LINC congress in Leipzig, Germany, it will become commercially available as of February 3, 2025, in line with country-specific market regulations.
The BeFlared FEVAR Stent Graft System in short:
The BeFlared is the world’s first dedicated bridging stent for FEVAR procedures. The stent is crimped on a specially designed stepped balloon which will reduce the number of steps that are needed for optimal placement. Additionally, a third radiopaque marker aids in optimal positioning of the stents in the fenestration. The BeFlared is available in diameters from 5 to 9 mm and in stent lengths of 22, 27 and 37 mm. The flared diameter is 2 to 3 mm larger compared to the native sizing of the stent. All devices are available on a 90 or 120 cm catheter.
About Bentley
Founded in 2009 by Lars Sunnanväder and Miko Obradovic, Bentley InnoMed GmbH is based in the medical technol¬ogy stronghold of Hechingen in Baden-Wurttemberg, Germany. The company develops, manufactures, and markets implants and catheters for the endovascular treatment of peripheral vascular and aortic diseases. The company has since then become a leading global manufacturer and the European market leader for covered stents. The company is part of the Bentley Endovascular Group. More than 440 employees are committed to the Group’s strong culture of innovation, making Bentley one of the most important employers in the county of Zollernalb and beyond. Based on its product innovations and the development of new markets, the company is on a path of strong growth momentum.
