First Patient enrolled in the clinical study of Bentley’s BeGraft and Cook’s Zenith® Fenestrated+ Endovascular Graft

CAUTION - INVESTIGATIONAL DEVICE. Limited by United States law to investigational use. 

 

Bentley announced earlier this week the enrollment of the first US patient in Bentley’s BeGraft and Cook’s Zenith® Fenestrated+ Endovascular Graft (ZFEN+) clinical study. The procedure was performed by the Principal Investigator of the study, Dr. Gustavo Oderich (UT Health Houston, Houston).

“This has been a very important milestone for all of us having the first patient enrolled in this study. Thanks to COOKs ZFEN+ device in combination with Bentley’s BeGraft covered stents we can offer a tailored solution for patients suffering from complex aortic aneurysm,” said Dr. Oderich.

The U.S. Food and Drug Administration (FDA) has granted in the summer of 2023 approval for Cook Medical and Bentley to initiate a joined Investigational Device Exemption (IDE) study. This clinical study will assess the safety and effectiveness of the ZFEN+ used in combination with the investigational Zenith® Universal Distal Body 2.0 Graft (Unibody2), the investigational Bentley BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and the commercially available Zenith® Spiral-Z® AAA Iliac Leg Graft (ZSLE). 

“At Bentley we are pleased that the study potentially could bring this technique a step closer to the American patient suffering from aortic aneurysms” said Sebastian Büchert, CEO, Bentley. “Our covered stents are used all over the world in similar procedures and it would be great if we can have this treatment option available in the US as well, once the study is finished and the results are published”.

The ZFEN+ clinical study is a prospective, multi-center, single-arm study that will include sites in the United States and Europe. Bentley and Cook intend to enrol 102 patients in the pivotal study. The primary safety endpoint is a composite measure of device technical success and procedural safety within 30 days. Likewise, the primary effectiveness endpoint is a composite measure of freedom from aneurysm-related mortality and freedom from clinically significant re-intervention through 12 months post procedure. A composite measure is a group of variables collected during the clinical study and analyzed.

 

About Bentley

Founded in 2009 by Lars Sunnanväder and Miko Obradovic, Bentley InnoMed GmbH is based in the 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. Based on its product innovations and the development of new markets, the company is on a path of strong growth momentum.

 

Contact: Matthias Bleesen, Communication & Event Coordinator
m.bleesen@bentley.global, +49 7471 984 995 631