Cook, Baxter Endovascular AAA Grafts Among Second Wave In PMA Process
This article was originally published in The Gray Sheet
Executive Summary
Clinical trials for Cook, Inc.' s Zenith abdominal aortic aneurysm endovascular graft are expected to begin within the next 60 days pending FDA sign-off on the firm's investigational device exemption. The randomized clinical trial is expected to enroll 260 patients at 13 U.S. centers.