The 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+).
The clinical study will assess the safety and effectiveness of the ZFEN+ in combination with the Bentley InnoMed BeGraft balloon-expandable fenestrated endovascular aortic repair (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 abdominal aortic aneurysm (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 ZFEN+ clinical study is a prospective, multicenter, single-arm study that will include sites in the U.S. 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,” said Gustavo Oderich, MD from the University of Texas Health Science Center at Houston in Houston, Texas, who is the global principal investigator of the study.
“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.”
