Three-year data for Ovation Stent Graft System in Abdominal Aortic Aneurysm-TriVascular

TriVascular Technologies has presented three-year primary safety and performance metrics from the Ovation Pivotal Trial of the Ovation Abdominal Stent Graft System for treatment of Abdominal Aortic Aneurysms. At the three-year mark, the study continued to show strong clinical results. Specifically, the data showed 100% freedom from aneurysm rupture, 100% freedom from conversion to open surgical repair, 100% freedom from Type I & III endoleaks, and 100% freedom from device migration. These results were compelling when analyzing clinically complex patient subsets. Subset analysis of patients with proximal aortic neck lengths less than 10mm, as well as patients who presented with hostile aortic neck anatomy, showed 100% freedom from: Type I and III endoleaks; rupture; migration; and conversion to surgical repair.

Notably, the data continue to provide evidence of proximal aortic neck protection. The Ovation system's polymer-filled sealing rings are designed to insulate the aortic neck from blood pressure and do not exert chronic outward force on the vessel wall. The Ovation three-year data, unlike data from studies using conventional self-expanding stent grafts, show that the mechanism of proximal sealing does not provoke neck dilatation. The results were presented at the 2014 Joint Annual Meeting of the New England Vascular Society and Eastern Vascular Society by Manish Mehta, MD, MPH, Director of Endovascular Services at the Vascular Institute for Health & Disease in Albany, New York who was the principal investigator for the Ovation Pivotal Trial.

The Ovation Stent Graft System has CE Mark and was FDA approved in 2011.