Bentley’s BeFlared Bridging Stent for FEVAR Used in First-in-Human Procedure

November 26, 2024—Bentley InnoMed GmbH announced the first-in-human implantation of the BeFlared stent graft system, which recently received CE Mark certification as a dedicated bridging stent for fenestrated endovascular aneurysm repair (FEVAR).

The company noted that the first-in-human FEVAR procedure was performed by Professor Stéphan Haulon, MD, a vascular surgeon at the Hôpital Marie Lannelongue in Paris, France. The patient (aged 72 years) had a severe aortic aneurysm. The total procedure time was 80 minutes.

According to the company, Prof. Haulon implanted the aortic endoprosthesis via the femoral artery. Three BeFlared stents were positioned at the fenestrations of the endograft to ensure immediate sealing and maintaining of blood flow through the visceral arteries to vital organs. Prof. Haulon implanted one regular BeGraft stent at the fourth fenestration.

“I am happy to report that the BeFlared met all our expectations regarding ease of use during the intervention, duration, and matching the requirements of the patient’s anatomy,” commented Prof. Haulon in the company’s press release. “The recent certification of the BeFlared marks a milestone in the endovascular treatment of aortic aneurysms as it allows to shorten procedure times and therefore reduce x-ray exposure to patients and operation staff significantly.”

Prof. Haulon, one of Bentley’s medical advisors, continued, “This ‘2-in-1’ device creates a new standard for bridging stents in FEVAR procedures. The BeFlared is a game changer as it makes these interventions safer, faster, and enables better outcomes for the patients.”

The Bentley press release noted that the BeFlared stent is crimped on a specially designed stepped balloon that is intended to reduce the number of steps needed for optimal placement; 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. All devices are available on a 90 or 120 cm catheter, noted Bentley.

The BeFlared will be officially launched at LINC 2025, the Leipzig Interventional Course to be held January 28-30 in Leipzig, Germany. It will become commercially available on February 3, 2025, in line with country-specific market regulations.