![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » HUP Begins Clinical Trial of Technology to Treat TAA
HUP Begins Clinical Trial of Technology to Treat TAA
A clinical trial is underway at the Hospital of the University of Pennsylvania to study the safety and effectiveness of an endovascular medical device to treat life-threatening thoracic aortic aneurysms.
The clinical trial, called STARZ-TX2 (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2 Thoracic TAA Endovascular Graft), is open to patients diagnosed with a descending thoracic aortic aneurysm. STARZ-TX2 will compare the outcomes of patients treated with open surgery to patients treated with the Zenith TX2 Thoracic TAA Endovascular Graft, manufactured by Cook.
Specifically, the trial will assess device performance as well as patient survival and aneurysm rupture rates in the surgical and endovascular treatment groups over a 12-month period. The trial will enroll 275 patients at up to 35 medical institutions in the U.S. and Canada. Additional trial sites in Japan, Australia and Europe also will participate.
KEYWORDS FDAnews Device Daily Bulletin
Upcoming Events
-
21Oct