Bentley’s BeFlared FEVAR Bridging Stent System Granted FDA Breakthrough Device Designation 

September 24, 2025—Bentley InnoMed GmbH announced that the FDA has granted Breakthrough Device designation for the company’s BeFlared fenestrated endovascular aneurysm repair (FEVAR) bridging stent graft system.

According to the company, the BeFlared device combines a stepped balloon design with a third radiopaque marker, enabling precise and controlled one-step deployment within graft fenestrations. The design helps eliminate the need for a second flaring step, which may be associated with several clinical benefits, including reduced procedural time, lower fluoroscopy time, less radiation, and less wire manipulation.

“BeFlared addresses real challenges that physicians face in complex anatomies,” commented Professor Stéphan Haulon, MD, in the company’s press release. “It’s exciting to see regulators acknowledge its potential in such a decisive way.” Prof. Haulon is a vascular surgeon and serves as a scientific advisor to Bentley.

As noted in the company’s press release, the FDA assigns this designation to devices that are expected to provide a more effective treatment and offer significant advantages over existing approved alternatives. The recognition is a milestone in the company’s regulatory process in the United States, stated Bentley.

In January 2025, Bentley announced the European launch of the BeFlared device after receiving CE Mark certification in late 2024.