FDA Approves Cook's Zenith Alpha Thoracic Graft

September 17, 2015—Cook Medical announced that the US Food and Drug Administration has approved the company’s lower-profile Zenith Alpha thoracic endovascular graft for the treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair. Suitable vascular anatomy includes nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion with a length of at least 20 mm, and with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm.

According to Cook Medical, the approval of Zenith Alpha thoracic device was based on two pivotal clinical trials that studied the safety and effectiveness of the device in patients with aortic aneurysm/ulcer or blunt traumatic aortic injury.

The new addition to the company’s Zenith platform, the Alpha thoracic features a lower-profile introduction system, a broad range of sizes, and a 16-F to 20-F delivery system. The device was developed to address vascular access issues associated with larger-profile devices and to increase conformability in tortuous anatomy. The introduction system also features an ergonomic design that requires fewer procedural steps than previous designs to deploy the device while maintaining the precision and control of the Zenith platform.

In the company’s press release, Karl Illig, MD, commented, “Despite all the successes we’ve seen over the past few decades in endovascular aneurysm repair, we continue to be frustrated when we have to put a large sheath through iliac arteries that are smaller than the delivery system. Development, testing, and now approval of the Zenith Alpha thoracic device is long-awaited in this regard.” Dr. Illig is Professor of Surgery and director of the division of Vascular Surgery at the University of South Florida’s Morsani College of Medicine in Tampa, Florida.