19 July 2022 - Hechingen, Germany – Recruitment complete in FEVAR study for on-label use with Bentley BeGraft as bridging stent
Recruitment is now complete with 100 patients planned per protocol in the fenestrated endovascular aortic aneurysm repair (FEVAR) study that uses Bentley's (Bentley InnoMed, Hechingen, Germany) BeGraft peripheral balloon expandable covered stent as a bridging stent in complex aortic aneurysms, bringing on-label use in this indication a step closer.
Led by Eric Verhoeven, Professor of Vascular Surgery at the General Hospital Nuremberg, Paracelsus Medical University, Nuremberg, Germany, the open label study is evaluating the safety and performance of the BeGraft stent as a bridging stent in FEVAR for complex aortic aneurysms.
To date, none of the commercially available covered stents are indicated as a dedicated bridging stent in FEVAR procedures.
“FEVAR is currently a well-established, minimally-invasive option for patients with abdominal aortic aneurysms and who are not eligible for an open aortic repair," said Sebastian Büchert (CEO, Bentley). He added, “the use of bridging stents has always been done off-label and we see it as our responsibility to get the BeGraft indicated for those procedures."
"We already know the patency is very good with the BeGraft as bridging stent, and we know how to handle this device," said Professor Verhoeven, who has used bridging stents for over 13 years at his Nuremberg clinic. He states, “although we have not yet analysed the data, I’m not expecting any surprises other than the confirmation that the Bentley BeGraft covered stents do well in this indication.”
The study's two performance endpoints comprise technical success of the procedure and bridging stent patency after one year. Safety will be evaluated for the one-year time point comprised of the absence of procedure related complications and bridging stent-related endoleaks. One-year results are expected during the second half of 2023.
Regarding the potential on-label approval of the BeGraft peripheral in this context, Professor Verhoeven said: "If you can use something on-label, many surgeons, particularly in relation to hospital policy, and in relation to the legal ramifications, would not, out of choice, use an off-label product."
The study is a collaboration between the Foundation for Cardiovascular Research and Education (FCRE, Belgium) and Bentley and is approved by the German competent authority BfArM. German participating centres are the University Hospitals Aachen, University Clinic of Gießen & Marburg, University Clinic Hamburg-Eppendorf, LMU Munich, University Clinic Regensburg, University Heart Center Freiburg-Bad Krozingen, St. Franziskus Hospital Münster, Stuttgart Hospital and Nuremberg Hospital.
ClinicalTrials.gov Identifier: NCT03987035
Bentley was founded in 2009 by medical entrepreneurs Lars Sunnanväder and Miko Obradovic. The company has seen substantial growth since the launch of its first product in 2012, and today operates a global sales network in more than 80 countries. The six top-line products in Bentley’s portfolio are:
- BeGraft coronary (2012)
- BeGraft peripheral: first generation (2013); second generation (2015)
- BeSmooth peripheral (2014)
- BeGraft aortic (2016)
- BeGraft PLUS (2017)
- BeYond Venous (2020)
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