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

FDA: Class I Recall for Cook’s Thoracic Endovascular Grafts

The US Food and Drug Administration (FDA) has classified a recent safety notice issued by Cook Medical affecting their Zenith Alpha thoracic endovascular grafts as a class I recall, the agency ...
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, ...
Healio

Thoracic endovascular graft recall deemed serious

Please provide your email address to receive an email when new articles are posted on . The FDA has designated a recall of a thoracic endovascular graft as Class I, the most serious kind. Cook Medical ...
Healio

FDA grants premarket approval to thoracic endovascular graft

Please provide your email address to receive an email when new articles are posted on . The FDA has issued premarket approval to Cook Medical for a thoracic endovascular graft system for the treatment ...
Medscape

Endovascular Repair of Thoracic Aortic Disease: Overview of Current Devices and Clinical Results

The Zenith TX2 TAA Endovascular stent graft is designed as a two-piece modular endograft system for thoracic aneurysm repair application. Both the proximal and distal endograft components are a ...