Cook Medical has announced that its Zenith iliac branch device (ZBIS) is now commercially available in the USA with US Food and Drug Administration (FDA) approval as an endovascular treatment option for aortoiliac or iliac aneurysmal disease.
The company has also shared that first implantations of the ZBIS were performed at several centres in the USA.
According to Cook, the ZBIS—when used with the necessary additional components (Zenith AAA 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 abdominal aortic aneurysm (AAA) device alone and when the vessel morphology is suitable for repair.
“This product offers an endovascular treatment option for many patients who do not meet the criteria of other commercially available technology. The ZBIS anatomical inclusion criteria is broader and is backed by five-year pivotal data. It’s a great addition to Cook’s portfolio of aortic devices that addresses an important patient need,” said Johnny LeBlanc, director of Cook Medical’s Aortic specialty.
