Cook Medical has received premarket approval from the U.S. Food and Drug Administration (FDA) for its lower-profile Zenith Alpha Thoracic Endovascular Graft.
Zenith Alpha Thoracic 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 Thoracic 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 Thoracic 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 Thoracic 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’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," said Karl Illig, MD, Professor Surgery and director of the division of Vascular Sugary at USF Morsani College of Medicine.
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 US.