Bentley's BeGraft Aortic Stent Graft System Launched in Europe

December 6, 2016—Bentley announced that it has launched its BeGraft aortic stent graft system, a balloon-expandable, large-diameter covered stent, which has received European CE Mark approval. The device is now commercially available in all countries that recognize the CE mark.

The BeGraft aortic device is indicated for the implantation in native and/or recurring coarcation of the aorta in adolescent or adult patients, as well as for restoring and improving the patency of the iliac arteries. Diameters are available from 12 to 24 mm, with lengths that range from 19 to 59 mm.

The company noted that the entire diameter range is covered by three different stent designs to guarantee low foreshortening combined with the high radial force of the stent; additionally, the device's flexibility contributes to optimized lesion care.

The BeGraft aortic graft system is composed of cobalt chromium and is mounted on a semicompliant balloon, which allows a slight variation in diameter. The stent graft allows high postdilation when using a large-diameter, high-pressure balloon. For example, the diameter of 12 mm can be postdilated up to 20 mm, and the 24 mm postdilated up to 30 mm, according to the company.

Prof. Piotr Kasprzak, MD, Head of Vascular Surgery, University Hospital Regensburg in Regensburg, Germany, performed the first BeGraft aortic implantation in early November. In the company's announcement, Prof. Kasprzak commented, "I am very pleased that a balloon-expandable, large-diameter stent graft is now easily available with which I can treat coarctations securely and accurately."

Peter Goverde, MD, of ZNA Stuivenberg Hospital in Antwerp, Belgium, added, “With BeGraft aortic, we now have a valuable and safe alternative for treating aortic and iliac lesions.”