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January 25, 2016
First Patient in United States Treated With Cook Medical's Zenith Alpha Thoracic Device
January 26, 2016—Cook Medical announced the first commercial use of the company’s Zenith Alpha thoracic endovascular graft in the United States. The company announced US Food and Drug Administration approval of the device on September 17, 2015. The first patient was treated in November at The Cleveland Clinic in Cleveland, Ohio.
According to the company, the Zenith Alpha thoracic device, with a 16–20-F delivery system, 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 Zenith Alpha was developed to provide vascular access and delivery with a lower profile device, which allows physicians to consider thoracic endovascular aortic repair options for patients who otherwise may not have been candidates for larger-profile devices.
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