Cook Medical’s ZFen+ Endovascular Graft Receives IDE Approval for Aortic Aneurysm Study

June 26, 2023—Cook Medical announced that it received approval from the FDA to initiate an investigational device exemption study of the company’s Zenith Fenestrated+ (ZFen+) endovascular graft.

According to Cook Medical, the prospective, multicenter, single-arm study will assess the safety and effectiveness of ZFen+—in combination with Bentley’s BeGraft balloon-expandable fenestrated endovascular aortic aneurysm repair bridging stent graft system—for the endovascular treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.

The primary safety endpoint is a composite measure of device technical success and procedural safety within 30 days. The primary effectiveness endpoint is a composite measure of freedom from aneurysm-related mortality and from clinically significant reintervention through 12 months postprocedure.

The ZFen+ clinical study will include sides in the United States and Europe. FDA has approved enrollment of the first 30 patients, and Cook noted in the press release that it plans to enroll 102 patients.

According to Cook Medical, ZFen+, which received FDA Breakthrough Device designation in March 2021, is based on the company’s commercially available Zenith Fenestrated abdominal aortic aneurysm endovascular graft but extends the proximal margin of aneurysmal disease that can be treated endovascularly.

“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,” remarked Global Principal Investigator Gustavo Oderich, MD.

Dr. Oderich continued, “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.”