Bentley’s BeGraft and BeFlared Gain TÜV Certification as Bridging Stents for FEVAR

November 20, 2024—Bentley InnoMed GmbH announced it has been granted two TÜV certificates that extend indications for its stents in complex aortic interventions in all countries that recognize CE Mark approval.

One certificate is for the Bentley BeGraft stent as an on-label bridging device and the other certificate is for the newly developed BeFlared, a dedicated bridging stent, for fenestrated endovascular aneurysm repair (FEVAR).

In the coming weeks, selected clinical centers will be implanting the new Bentley covered stents for FEVAR procedures. The official market launch is planned at LINC 2025, the Leipzig Interventional Course to be held January 28-30 in Leipzig, Germany.

According to the company, the path to certification was paved by results from a study conducted by Professor Eric Verhoeven, MD, who is Professor of Vascular Surgery at the Paracelsus Medical University in Nuremberg, Germany. In July 2022, Bentley announced the completion of recruitment of more than 100 patients at 10 centers in the BGP Stent as Bridging Stent in FEVAR study evaluating the safety and performance of FEVAR using the BeGraft peripheral balloon-expandable covered stent as a bridging stent in complex aortic aneurysms. Commencement of the multicentric clinical trial announced in March 2021.

“For more than 15 years, interventional radiologists and endovascular surgeons around the globe have performed FEVAR procedures with off-label stents,” commented Prof. Verhoeven in the company’s press release. “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.”

The company stated that the BeFlared dedicated bridging stent connects the fenestrations of aortic prostheses to the patient’s renal and visceral arteries. It is composed of a 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 permit accurate deployment in one step, which prevents future complications such as endoleaks, noted Bentley.