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January 29, 2025
Bentley’s BeGraft and BeFlared FEVAR Bridging Systems Launched in Europe
January 29, 2025—Bentley InnoMed GmbH announced the launch of the BeGraft stent graft system, an on-label bridging device for fenestrated endovascular aneurysm repair (FEVAR) procedures, and the BeFlared stent graft system, a dedicated bridging stent indicated for FEVAR procedures.
According to the company, the BeFlared FEVAR device features a stent crimped on a specially designed stepped balloon that will reduce the number of steps that are needed for optimal deployment. Also, 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, advised Bentley.
The launches were announced at LINC 2025, the Leipzig Interventional Course held January 28-30 in Leipzig, Germany. On the first day of LINC 2025, Bentley announced the market launch of its BeFlow iliac covered stent system in Europe.
On November 20, 2024, Bentley announced TÜV certificates for the BeGraft and BeFlared systems that extended indications for the stents in complex aortic interventions in all countries that recognize CE Mark approval. The BeFlared is now commercially available in line with country specific market regulations.
On November 26, the company announced that the first-in-human implantation of the BeFlared stent graft system was performed by Professor Stéphan Haulon, MD, a vascular surgeon at the Hôpital Marie Lannelongue in Paris, France.
At LINC 2025, Prof. Haulon will present his first experiences with the BeFlared and will discuss the advantages in FEVAR procedures and he will perform a live case in which he will be using the BeFlared stent on January 30.
“This dedicated bridging stent allows precise positioning and accurate deployment thanks to a third extra marker on the balloon catheter,” commented Prof. Haulon in the company’s press release, “The specially designed ‘stepped’ balloon will make sure that the stent can be inflated in one step (positioning and flaring). This is not only a game changer, but one of the most important milestones in the history of fenestrated aortic endografting.”
Findings from the early experience regarding usability and initial clinical outcomes with the BeFlared stent were recently published online by Athanasios Katsargyris, MD, et al for the early launch collaborators in the European Journal of Vascular Surgery. The early launch collaborators stated that the BeFlared will make fenestrated endografting simpler and swifter, noted the company.
“We are pleased that the first experiences with the device confirm a shorter overall time for procedural and fluoroscopy per target vessel,” stated Prof. Haulon in Bentley’s press release.
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