TCTMD

Cook Medical Receives FDA Approval for the Zenith Alpha™ Thoracic Endovascular Graft

BLOOMINGTON, Ind., 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 ...
TCTMD

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 ...
WSOC-TV

Cook Medical Issues Recall Correction of Zenith Alpha™ Thoracic Endovascular Graft and Removes

Cook Medical initiated a correction to the Instructions For Use (IFU) for the Zenith Alpha™ Thoracic Endovascular Graft. This correction removed the indication for blunt thoracic aortic injury, also ...
MD&M East

Cook Clears Up Confusion Incited By Zenith Recall

A recent Cook Medical recall stirred up quite a bit of confusion after FDA classified it as a Class I recall late last week. The device in question is the Zenith Alpha Thoracic Endovascular Graft, ...