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US Food and Drug Administration (FDA) Approves Zenith Alpha Thoracics Endovascular Graft

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Published on : Sep 22, 2015

The US Food and Drug Administration (FDA) recently gave a premarket approval to Cook Medical for its Zenith Alpha Thoracic endovascular graft, its lower-profile product. Zenith Alpha Thoracic has been designed for treating endovascular patients with isolated lesions towards the descending thoracic aorta. This approval came through with two clinical trials that assured effectiveness and safety of the device for treating the blunt traumatic aortic injury or aortic aneurysm/ulcer.

The device, TEVAR (thoracic endovascular aortic repair), will help in treating a huge number of patients due to its lower-profile and a wide number of sizes. The device has a 16-20 French delivery system which is aimed at addressing vascular access issues related to larger-profile devices along with making it easy to navigate from the anatomy. 

The device has been ergonomically designed and thus needs lesser number of steps for launching the procedure without compromising on the control and precision of the Zenith platform.

Karl Illig, MD, professor surgery and director of the division of vascular surgery at USF Morsani College of Medicine stated that despite the evolution of the endovascular aneurysm repair surgeries, the frustration of inserting a huge sheath all the way through iliac arteries was never eliminated. Thus, this approval has been a long-awaited one. 

Nicky James, global business unit leader and vice president and of Cook Medical’s aortic intervention division stated that this approval will expedite the vision Cook Medical has to offer physicians a disease-specific treatment solution that will cater to every unique case, in a unique manner