Cook Medical has received premarket approval from the US Food and Drug Administration (FDA) for its lower-profile Zenith Alpha thoracic endovascular graft.
Zenith Alpha is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair. The approval of Zenith Alpha 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.
Zenith Alpha will allow physicians to treat more patients with TEVAR (thoracic endovascular aortic repair) because of its lower-profile introduction system and broad range of sizes. With a 16–20 French delivery system, Zenith Alpha was developed to address vascular access issues associated with larger-profile devices and to increase conformability in tortuous anatomy. The device’s introduction system also features an ergonomic design that requires fewer procedural steps than previous designs to deploy the device without sacrificing the precision and control of the Zenith platform.
“Despite all the successes we have 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,” said Karl Illig, professor of surgery and director of the division of Vascular Surgery at USF Morsani College of Medicine, Tampa, USA. “Development, testing, and now approval of the Zenith Alpha thoracic device is long-awaited in this regard.”
“The approval of Zenith Alpha thoracic accelerates Cook Medical’s vision to provide physicians with disease-specific treatment options that fit each patient’s unique anatomy and disease state,” said Nicky James, vice president and global business unit leader of Cook Medical’s Aortic Intervention division.
Zenith Alpha thoracic was first launched in Europe following CE mark approval in 2013 and is the newest addition to a growing portfolio of clinically proven Zenith endovascular grafts and procedural accessories in the USA.