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First Patient Enrolled in Clinical Study for CERAB With Bentley Covered Stents
Hechingen, Germany: The first patient has been enrolled in an investigator-initiated study on the treatment of aorto-iliac occlusive disease (AIOD) with the CERAB technique (covered endovascular reconstruction of the aortic bifurcation) using a combination of the Bentley BeGraft aortic Stent Graft System and the BeGraft peripheral Stent Graft System. Dr. Ioannis Passaloglou, chief physician of vascular surgery of St. Gertrauden Hospital, Berlin, successfully performed this minimally invasive procedure. The study is conducted by the Foundation for Cardiovascular Research and Education, approved by the German and Dutch competent authorities, and supported by Bentley.
AIOD diminishes blood flow to the legs and is one of the causes of limb amputation. The CERAB technique in combination with the BeGraft aortic and two BeGraft peripheral stents provide a treatment option especially for high-risk patients for whom open surgery is unsuitable.
“Due to our close contact with leading endovascular experts, we see a rising use of covered stents in the CERAB procedure to remedy AIOD. As so far none of the available covered stents are indicated for this new treatment option, Bentley wants to take on the responsibility to prepare the certification for an on-label application. The enrolment of the first patient in this clinical study is a decisive step to get the CERAB-indication for our BeGraft aortic and BeGraft peripheral stents,” said Sebastian Büchert, CEO of Bentley.
“We are happy to contribute to the clinical investigation on the endovascular treatment of AIOD. The CERAB technique has shown great results so far, and in combination with the Bentley stents, the treatment has major advantages compared to the “kissing stent” technique or the open approach,” said Dr. Ioannis Passaloglou, coordinating investigator of the multi-center clinical study. “Although the procedure is still off-label, the complication rate is lower and the patients’ recovery faster. Together with further clinical data, it may become the new gold standard for treating AIOD and to increase the patency rates in the long-term,” Dr. Passaloglou added.
In general, approximately 16 sites in Germany and the Netherlands will participate in the study. 109 patients will be included with a follow-up period of 24 months.
“This prospective clinical trial will support the on-label certification of the Bentley BeGraft aortic and BeGraft peripheral for the treatment of AIOD. We assume that it will further prove the long-lasting positive therapeutic effects of the CERAB technique leading to a reduced perioperative mortality and morbidity versus open surgical procedures for patients severely suffering from AIOD,” said Dr. Martin Schirling, Clinical Affairs Manager at Bentley.
ClinicalTrials.gov Identifier: NCT05805111
About Bentley Innomed GmbH Founded in 2009 by Lars Sunnanväder and Miko Obradovic, Bentley InnoMed GmbH is based in the 2 medical technology stronghold of Hechingen in Baden-Wurttemberg, Germany. The company develops, manufactures, and markets implants and catheters for the endovascular treatment of peripheral vascular and aortic diseases. The company has since then become a leading global manufacturer and the European market leader for covered stents. The company is part of the Bentley Endovascular Group. More than 400 employees are committed to the Group’s strong culture of innovation, making Bentley one of the most important employers in the county of Zollernalb and beyond. In 2022, the company generated sales revenue of EUR 69 million.
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