Bentley’s BeFlow Covered Stent for Iliac Occlusive Diseases Launched in Europe

January 28, 2025—Bentley InnoMed GmbH announced the market launch of its BeFlow iliac covered stent system, which will be commercially available in Europe as of February 2025.

Bentley advised it will conduct a postmarket clinical follow-up study to be led by Principal Investigator Antonella Ruffino, MD, of Lugano, Switzerland.

According to the company, the CE Mark–approved BeFlow covered stent is intended for the treatment of iliac occlusive and stenotic diseases. The device comes in four diameters of 7 to 10 mm and two nominal lengths of 37 and 57 mm.

The launch was announced at LINC 2025, the Leipzig Interventional Course held January 28-30 in Leipzig, Germany.

Bentley reported that the first-in-human procedure with the device was conducted by Koen Deloose, MD, on a patient (age, 78 years) who was experiencing severe claudication. Dr. Deloose is Head of Vascular Surgery AZ Sint-Blasius Hospital in Dendermonde, Belgium.

“The BeFlow is a great solution for patients with complex aorto-iliac occlusive disease,” commented Dr. Deloose in the company’s press release. “When dealing with more simple lesions, Bentley offers an established uncovered balloon expandable stent, the BeSmooth, with the same product features such as a low profile, high visibility and flexibility that we know from the already proven design from the BeGraft.”

Dr. Deloose continued, “Regarding ease of use during the endovascular intervention, the new BeFlow fulfills all requirements. Particularly, in heavily stenosed or even occluded iliacs, a covered stent is the preferred solution, as it will ensure long-term patency and is in line with the European Society for Vascular Surgery guidelines for iliac stenting, where it is stated that covered stents may be considered due to higher patency rates.”