Cook Medical’s Zenith® Iliac Branch Device (ZBIS)
Bloomington, Ind. — Cook Medical’s Zenith® Iliac Branch Device (ZBIS) is now commercially available in the United States with FDA approval as an endovascular treatment option for aortoiliac or iliac aneurysmal disease. Cook is excited to bring this advanced product to the US and improve the lives of patients with aortoiliac or iliac aneurysms.
Cook is also excited to announce several of the first implants of ZBIS in the United States. The physicians who performed the first implants include:
- Andres Fajardo, IU Health Methodist Hospital
- James Black III, Johns Hopkins Hospital
- Karan Garg, NYU Langone Medical Center
- Jason Lee, Stanford Hospital
- Caitlin Hicks, Johns Hopkins Hospital
“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 5-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.
About ZBIS
When patients suffer from aortoiliac or iliac aneurysms, they risk clots and ruptured aneurysms. The ZBIS graft treats aortoiliac or iliac aneurysms and provides patients an improved quality of life through 5 years.
The ZBIS graft treats aortoiliac or iliac aneurysms while maintaining blood flow to the internal iliac artery. Built on the proven Zenith platform, ZBIS expands Cook’s current aortic portfolio to include treatments for iliac and aortoiliac aneurysms. This graft offers benefits such as:
- Preserving a patient’s quality of life by preserving internal iliac function and reducing the incidence of buttock claudication, impotence, and other ischemic complications. 1
- Delivering a durable aneurysm repair with long-term data to support 0% iliac artery aneurysm enlargement on the ZBIS side. 1
- Treating a wide range of patients by having a smaller device proximal diameter of 12mm and offering two common iliac segments lengths (45 mm and 61 mm).
FDA approved the Zenith Iliac Branch on 30 May 2025. The Zenith Iliac Branch, 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 AAA device alone and when the vessel morphology is suitable for repair.
To learn more about ZBIS, you can visit the product page here.
About Cook Medical
At Cook Medical, we are passionate about making unique, quality medical devices and connecting with people to improve lives. Founded on inventing, manufacturing, and delivering medical devices, we provide healthcare professionals with the tools they need to help their patients return to living.
Our commitment to innovation involves bringing new products to market and keeping existing products relevant to a changing healthcare landscape. We believe in using our business to help people and communities thrive by creating inclusive, supportive, and healthy environments.
We are proud of our history of innovative firsts and the impact we have on patients and communities. With headquarters in Bloomington, Indiana, and manufacturing facilities and offices in various global locations, we challenge ourselves to maintain a global perspective while focusing on local impact.
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1 US Pivotal Clinical Trial Data PMA (P020018/S064)
A total of 40 patients were treated with ZBIS and the iCast covered stent between 01 April 2014 and 06 May 2015. Study patients were enrolled across 18 investigational sites in the United States.
