Bentley BeGraft Peripheral Plus Stent Evaluated as Bridging Stent in BEVAR Procedures

March 10, 2023—Bentley InnoMed GmbH announced that recruitment has been completed in a clinical study evaluating the safety and performance of the company’s BeGraft Peripheral Plus (BGP+) expandable covered stent as a bridging stent in branched endovascular aortic repair (BEVAR) procedures. The study is being conducted to support on-label use for this indication.

According to the company, the BGP+ Stent as Bridging Stent in BEVAR study has enrolled more than 100 patients as planned per protocol. In September 2020, Bentley announced the recruitment of the first patient in the trial.

The endpoints for the study include the technical success of the procedure and the patency of the bridging stent after 1 year. Safety will be evaluated for the 1-year time point and will include the absence of procedure-related complications and endoleaks associated with the bridging stents. Results are expected in the second half of 2024, advised the company.

The study is led by Professor Martin Austermann, MD, who is a vascular surgeon at St. Franziskus Hospital in Münster, Germany, and Assistant Professor of Vascular Surgery at the University of Münster.

“In BEVAR interventions, bridging stents are not supported by the native vessel wall, so the risk of failure is high,” commented Prof. Austermann in Bentley’s press release. “Although we have not yet analyzed study data, the BeGraft Peripheral Plus with its special design met the requirements of high radial force combined with flexibility quite well.

“At first glance the data are promising, and with the potential indication for on-label usage as a bridging stent in BEVAR procedures, it will change the approach from the physicians’ perspective.”

The BGP+ Stent as Bridging Stent in BEVAR study is a collaboration of Bentley and the Foundation for Cardiovascular Research and Education in Belgium.

It has been approved by the German competent authority BfArM. Participating centers in Germany include the St. Franziskus Hospital Münster, University Hospitals Aachen, University Clinic Hamburg-Eppendorf, LMU Munich, University Clinic Regensburg, Stuttgart Hospital, University Hospital Leipzig, University Hospital Heidelberg, University Hospital Schleswig-Holstein-Kiel, and the Nuremberg Hospital.

In the company’s press release, Sebastian Büchert, CEO of Bentley, stated, “At Bentley, we became aware that a significant share of the BeGraft Peripheral Plus is being used as a bridging stent for the treatment of thoracoabdominal aneurysms in BEVAR procedures. Since none of the available covered stents are holding this indication, Bentley aims to step up and bring this off-label application on-label.”