FDA Grants Premarket Approval to Cook for Zenith Alpha Thoracic Endovascular Graft
The FDA has granted premarket approval to Cook Medical for its Zenith Alpha Thoracic Endovascular Graft, indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta.
The approval was based on two pivotal clinical trials that studied the safety and effectiveness of the device in patients with aortic aneurysm or blunt traumatic aortic injury.
According to Bloomington, Ind.-based Cook, the device’s lower profile introduction system and broad range of sizes will allow physicians to treat more patients with thoracic endovascular aortic repair.
The graft was launched in Europe after receiving CE Mark approval in 2013. — Michael Cipriano