First U.S. Patient Treated Following FDA Approval of Cook Medical’s Zenith Alpha™ Thoracic Endovascular Graft


BLOOMINGTON, Ind., In November, following the Food and Drug Administration approval of Cook Medical’s Zenith Alpha
 Thoracic Endovascular Graft, the first patient was treated with the device in the U.S.

“The first commercial use of Zenith Alpha Thoracic in the U.S. represents significant progress toward Cook’s goal of providing a range of devices that address each patient’s unique disease pathology,” said Nicky James, vice president and global business unit leader of Cook Medical’s Aortic Intervention division. “We firmly believe in fitting the device to the patient, not the patient to the device. We are extremely proud to bring this technology to American physicians and the patients who need it.”

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.1 With a 16-20 French delivery system, Zenith Alpha Thoracic was developed to provide vascular access and delivery with a lower profile device which allows physicians to consider TEVAR (thoracic endovascular aortic repair) options for patients who otherwise may not have been candidates for larger-profile devices.

The Cleveland Clinic was the first to treat a patient with the device in the U.S. following the approval.

Zenith Alpha Thoracic is the newest addition to a growing portfolio of clinically proven Zenith endovascular grafts and procedural accessories in the U.S.

Source: Cook Medical

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