Three-Year Data Presented From TriVascular's Ovation Pivotal Trial

September 12, 2014—TriVascular, Inc. announced the presentation of 3-year primary safety and performance metrics from the Ovation pivotal trial by Principal Investigator Manish Mehta, MD, at the 2014 Joint Annual Meeting of the New England Vascular Society and Eastern Vascular Society. The objective of the Ovation pivotal trial is to evaluate the safety and effectiveness outcomes of the low-profile, 14-F outer diameter Ovation abdominal stent graft system for endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms.

In October 2012, the company announced US Food and Drug Administration approval of the device and announced European CE Mark approval in September 2010.

As summarized by TriVascular, the Ovation pivotal trial enrolled 161 patients across 36 sites and three countries. An additional 77 patients were treated in a Continued Access arm at 28 sites in the United States. In the pivotal study cohort, approximately 40% of the patients treated would be considered off-label for conventional stent graft placement, noted the company.

At the 3-year mark, the study continued to show strong clinical results with 100% freedom from aneurysm rupture, 100% freedom from conversion to open surgical repair, 100% freedom from type I and III endoleaks, and 100% freedom from device migration. 

According to TriVascular, these results were compelling when analyzing clinically complex patient subsets, including patients with proximal aortic neck lengths of < 10 mm and in patients who presented with hostile aortic neck anatomy. The subset analysis showed 100% freedom from type I and III endoleaks, rupture, migration, and conversion to surgical repair.  

Also, the Ovation 3-year data continue to provide evidence of proximal aortic neck protection. The data show that the mechanism of proximal sealing does not provoke neck dilatation—unlike that shown in data from studies using conventional self-expanding stent grafts. 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, stated TriVascular.

In the company’s press release, Dr. Mehta commented, “I’m encouraged by the 3-year results from the Ovation pivotal trial. The follow-up suggests that the Ovation system is an important addition to the treatment toolkit for EVAR practitioners. The safety and performance metrics are compelling across a broad range of patients, but especially so when you consider the clinical complexity of this study’s patient cohort. Many of the patients treated in the trial would not be eligible for on-label EVAR prior to the Ovation platform. I look forward to additional trial results as patient follow-up and subset analysis continues.” Dr. Mehta is Director of Endovascular Services at the Vascular Institute for Health & Disease in Albany, New York.