November 20, 2024 — Bentley InnoMed GmbH announced that it has obtained two TÜV certificates that expand the 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 bypass device and the other certificate is for the new BeFlared, a dedicated bypass stent, for fenestrated endovascular aneurysm repair (FEVAR).

In the coming weeks, selected clinical centers will implant the new Bentley Covered Stents for FEVAR procedures. The official market launch is planned during LINC 2025, the Leipzig Interventional Course which will be held January 28-30 in Leipzig, Germany.

According to the company, the path to certification was opened by the results of a study led by Professor Eric Verhoeven, MD, professor of vascular surgery at Paracelsus Medical University in Nuremberg, Germany. In July 2022, Bentley announcement the finalization of the recruitment of more than 100 patients in 10 centers BGP stent as a bypass stent in the FEVAR study evaluating the safety and performance of FEVAR using the BeGraft balloon expandable peripheral covered stent as a bypass stent in complex aortic aneurysms. Start of multicenter clinical trial announcement in March 2021.

“For over 15 years, interventional radiologists and endovascular surgeons around the world have been performing FEVAR procedures with non-compliant stents,” commented Professor Verhoeven in the company’s press release. “I am very pleased that the BeGraft is now certified for use as a bypass stent. BeGraft has proven to be a means of choice when treating patients with difficult aortic aneurysms.

The company said the BeFlared dedicated bypass stent connects the fenestrations of aortic prostheses to the patient’s renal and visceral arteries. It consists of a shaped balloon on which the stent is mounted. The conical shape of the balloon seals the BeFlared stent in the fenestration. A third radiological marker at the point of fenestration allows precise positioning of the stent. Both of these features enable precise, single-step deployment, which avoids future complications such as endoleaks, Bentley noted.