The US Food and Drug Administration (FDA) has granted pre-market approval to Cook Medical‘s lower-profile Zenith Alpha Thoracic Endovascular Graft, which is indicated for the endovascular treatment.
Zenith Alpha Thoracic is specifically indicated for endovascular treatment of patients with isolated lesions of the descending thoracic aorta, excluding dissections, and having vascular anatomy suitable for endovascular repair.
FDA’s approval is based on two pivotal clinical trials, which assessed the device’s safety and effectiveness in patients with aortic aneurysm/ulcer or blunt traumatic aortic injury.
Cook Medical Aortic Intervention division vice-president and global business unit leader Nicky James said: "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."
USF Morsani College of Medicine vascular surgery division director Dr Karl Illig said: "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."
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The device, which is fitted with a 16-20 French delivery system, is available in a broad range of sizes to help address vascular access issues related with larger-profile devices and to increase conformability in tortuous anatomy.
Featuring an ergonomic design and a lower-profile introduction system, Zenith Alpha Thoracic allows physicians to treat more patients with thoracic endovascular aortic repair.
In 2013, Zenith Alpha Thoracic obtained CE Mark approval and made its debut in Europe.