Cook’s Zenith Iliac Branch Device Approved and Launched in United States

July 14, 2025—Cook Medical announced that its Zenith iliac branch device (ZBIS) is now commercially available in the United States. The first implantations of the device have been performed at several centers across the country.

The company advised that on May 30 the ZBIS device received FDA approval as an endovascular treatment option for aortoiliac or iliac aneurysmal disease.

According to Cook Medical, ZBIS—when used with the necessary additional components (the Zenith abdominal aortic aneurysm [AAA] device and a covered bridging stent)—is indicated for the endovascular treatment of patients with an aortoiliac or iliac aneurysm to preserve internal iliac arterial blood flow when the distal sealing site in the common iliac artery is insufficient for the AAA device alone and when the vessel morphology is suitable for repair.

The company stated that the ZBIS features a proximal diameter of 12 mm and two common iliac segment lengths of 45 and 61 mm to treat a wide range of patients.

The ZBIS delivers durable aneurysm repair with long-term data to support 0% iliac artery aneurysm enlargement on the ZBIS side, as shown in its United States pivotal trial, noted Cook Medical. 

Additionally, the device’s quality-of-life benefits include preserving internal iliac function and reducing the incidence of buttock claudication, impotence, and other ischemic complications, stated the company.