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, ...
BLOOMINGTON, Ind.--(BUSINESS WIRE)--Following the recent FDA approval of Cook Medical’s Zenith Dissection Endovascular System, Cooper University Health Care in Camden, New Jersey, has treated the ...
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 ...
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 ...
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 ...