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Double Win With Bridging Stents: FEVAR Certifications for BeGraft and BeFlared
Hechingen, November 20th, 2024. With two certificates granted by TÜV, Bentley achieved another break-through in extending indications for its stents in complex aortic interventions. Thanks to one certificate, the Bentley BeGraft stent now is the world’s first on-label bridging device. The second certificate was received for the newly developed BeFlared, the first-to-market dedicated bridging stent for FEVAR (Fenestrated EndoVascular Aneurysm Repair). Thus, the leading manufacturer of balloon-expandable covered stents again fulfills its dedication to ease the work of physicians and improve clinical outcomes for patients.
FEVAR procedures are necessary when patients suffer from aneurysms extending up to the renal or visceral arteries. In a minimally invasive intervention under X-Ray, custom-designed aortic endo-grafts are implanted to exclude the aneurysm. This procedure requires additional bridging stents to ensure perfusion of vital organs. “For more than 15 years, interventional radiologists and endovascular surgeons around the globe have performed FEVAR procedures with off-label stents. I am very happy that now the BeGraft is certified for use as a bridging stent. The BeGraft has successfully proven to be a means of choice when treating patients with challenging aortic aneurysms”, said Eric Verhoeven, Professor of Vascular Surgery at the Paracelsus Medical University Nuremberg (Germany). Starting in 2021, he had conducted a multi-centric clinical trial using BeGraft in FEVAR procedures with more than 100 patients at 10 participating study centres. The positive results of this study paved the way for the certification initiated by Bentley.
“This certificate for the extended indication of our BeGraft stent graft system certainly is a milestone and improves our competitive edge in serving hospitals, physicians and patients with reliable endovascular solutions. Yet in face of the ever-rising need for FEVAR procedures in aortic repair, we also heavily invested in the development of the next generation bridging stent dedicated to FEVAR procedures: the BeFlared. It right now received the CE-certificate for the use in FEVAR procedures”, Bentley’s CEO Sebastian Büchert remarked on the double win.
The swift certification of the BeFlared is the result of more than four years hard development work of the Bentley team. It was initiated by Bentley’s co-founder Miko Obradovic who came up with the principal idea of a product simplifying bridging stent placement after being present at FEVAR procedures. The project team then developed the BeFlared in cooperation with Bentley’s long-standing scientific advisor Prof. Stéphan Haulon, a leading French endovascular surgeon from the Hôpital Marie Lannelongue at Paris University, together with a team of other international endovascular specialists.
As a dedicated bridging stent, the BeFlared connects the fenestrations of aortic prostheses to the patient’s renal and visceral arteries. It consists of a uniquely shaped balloon on which the stent is mounted. The tapered shape of the balloon seals the BeFlared stent within the fenestration. A third x-ray marker at the point of the fenestration allows precise positioning of the stent. These two features 2 permit accurate deployment in one step, which is decisive to prevent future complications such as endo-leaks.
In the coming weeks, selected clinical centres will be implanting the new Bentley covered stents for FEVAR procedures. The official market launch is planned at the LINC congress taking place in January, 28th-30th, 2025 in Leipzig, Germany.
About Bentley
Founded in 2009 by Lars Sunnanväder and Miko Obradovic, Bentley InnoMed GmbH is based in the medical technology 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.
