Cook Zenith TX2 Thoracic Aortic Aneurysm Graft On Track For 2006 Launch
This article was originally published in The Gray Sheet
Executive Summary
Cook is expanding the U.S. clinical trial of its Zenith TX2 thoracic aortic aneurysm (TAA) stent graft to include 220 patients at 35 centers, in line with FDA recommendations for patient follow-up
You may also be interested in...
Gore’s TAG Thoracic Endograft Is First To Go Before FDA Panel
A favorable recommendation by FDA's Circulatory System Devices Panel would place W.L. Gore one step closer to becoming the first firm with U.S. market approval for a thoracic aortic aneurysm endograft
Gore’s TAG Thoracic Endograft Is First To Go Before FDA Panel
A favorable recommendation by FDA's Circulatory System Devices Panel would place W.L. Gore one step closer to becoming the first firm with U.S. market approval for a thoracic aortic aneurysm endograft
FDA Relaxes AAA Panel Meeting Criteria; Thoracic Endograft Approvals Lag
Abdominal aortic aneurysm endograft applications will no longer require advisory panel review, unless new issues arise in the course of FDA's premarket evaluation