FDA Approves Cook Medical’s Zenith Dissection Endovascular System
February 4, 2019—Cook Medical announced FDA approval of its Zenith dissection endovascular system.
The system includes a proximal stent graft component and a distal bare-metal stent component to provide a less invasive alternative to open surgery for repair of type B dissections of the descending thoracic aorta.
Cook noted that the device will be available for sale in the United States within the coming months.
“We’re pleased to provide another minimally invasive option for aortic repair,” said Mark Breedlove, Vice President of Cook Medical’s Vascular division, in the company's announcement. “The approval of this product gives us an opportunity to have a positive impact on the lives of patients with aortic dissections.”