Cook Medical Enrolls First Patient in ZFEN+ Clinical Study

January 31, 2024—Cook Medical announced that the first patient was treated in the clinical study of the company’s Zenith Fenestrated+ (ZFen+) endovascular graft in the United States. The procedure was performed by Global Principal Investigator Gustavo Oderich, MD, at UT Health Houston in Houston, Texas.

The ZFEN+ clinical study is being conducted under an investigational device exemption from the FDA, which the company announced in June 2023.

“We are ecstatic at UT Health Houston to have treated this first ZFen+ patient,” commented Dr. Oderich in the company’s press release. “This is a huge step forward in getting the first patient-specific device for complex abdominal and extent 4 thoracoabdominal aneurysms with fenestrations. Rather than a one-size-fits-all approach, the ZFen+ device design aims to optimize patient needs.”

According to the company, the ZFEN+ clinical study will assess the safety and effectiveness of the ZFen+ device used in combination with Cook’s investigational Zenith Universal distal body 2.0 graft (Unibody2), Bentley’s investigational BeGraft balloon-expandable fenestrated endovascular aortic aneurysm repair bridging stent graft system, and Cook’s commercially available Zenith Spiral-Z abdominal aortic aneurysm iliac leg graft.

The study will enroll patients who need treatment of aortic aneurysms involving one or more of the major visceral arteries. Patients with juxtarenal, pararenal, and extent 4 thoracoabdominal aneurysms meeting specific anatomical requirements may be included in the study.

In 2021, Cook Medical announced that the ZFen+ patient-specific aortic endograft received FDA Breakthrough Device designation.

The company stated that the ZFen+ device is designed with fenestrations aligned to a patient’s unique anatomy and to extend the proximal margin of aneurysmal disease that can be treated endovascularly. It is based on Cook’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 is an investigational device limited by United States law to investigational use, advised Cook Medical.