CAUTION: Investigational device. Limited by United States law to investigational use.
Bloomington, Ind. — The U.S. Food and Drug Administration (FDA) has granted approval for Cook Medical to initiate an Investigational Device Exemption (IDE) study on the Zenith Fenestrated+ Endovascular Graft (ZFEN+).
This clinical study will assess the safety and effectiveness of the ZFEN+ in combination with the Bentley InnoMed BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) for the endovascular treatment of patients with aortic aneurysms involving one or more of the major visceral arteries. The ZFEN+ is predicated on the commercially available Zenith Fenestrated AAA Endovascular Graft, but extends the proximal margin of aneurysmal disease that can be treated endovascularly to include patients with more complex aortic disease. For patients with complex aortic disease, the only currently established treatment option is open surgical repair.
“The clinical community has been asking for a durable, low-profile commercial device that allows them to easily treat more patients. We pioneered this technology with key thought leaders and continue to listen and innovate to the market needs. The ZFEN+ has received Breakthrough Device Designation from the FDA, so we’re excited to see this innovation progress into a clinical study. The ZFEN+ is the next generation and future of fenestrated technologies,” said Johnny LeBlanc, Director of Aortic Product Management, Cook Medical.
“Outside the United States, Bentley has supplied 300,000 BeGraft stents to patients in 80 countries around the world. We are pleased that this study approval of the FDA brings us one step closer to making our leading technology also available to American patients suffering from vascular diseases,” said Sebastian Büchert, CEO, Bentley.
The ZFEN+ clinical study is a prospective, multi-center, single-arm study that will include sites in the United States and Europe. At this time, the FDA has approved enrollment of the first 30 patients. Ultimately, Cook intends to enroll 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 reintervention through 12 months post procedure. A composite measure is a group of variables collected during the clinical study and analyzed.
“The ZFEN+ Endovascular Graft will meet a significant need for our patients. There are not many options to treat complex aortic aneurysms other than open repair or off-label use of devices. Even long after off-the-shelf devices become available, the ZFEN+ will offer a tailored approach specific to the patient anatomy. The ZFEN+ clinical study will provide a benchmark for safety and effectiveness of a less invasive option to treat complex abdominal aortic aneurysms,” said Dr. Gustavo Oderich, who is the Global Principal Investigator of the study.
Additional information about the clinical study is available at www.clinicaltrials.gov.
About Cook Medical
Since 1963, Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we invent, manufacture and deliver a unique portfolio of medical devices to the healthcare systems of the world. Serving patients is a privilege, and we demand the highest standards of quality, ethics and service. We have remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities.