One-Year Results Published for TriVascular's Ovation Global Pivotal Study

August 26, 2013—TriVascular (Santa Rosa, CA) announced that 1-year outcomes from the TriVascular Ovation global pivotal study were published by Manish Mehta, MD, et al online ahead of print in Journal of Vascular Surgery.

According to the company, the study concluded, “[O]ne-year outcomes with the Ovation stent graft are promising, with excellent demonstrated safety and effectiveness in patients with AAA [abdominal aortic aneurysm]. These results were similarly remarkable in patients with challenging anatomical characteristics who would be ineligible for treatment with other approved stent grafts.”

In TriVascular's press release, Dr. Mehta commented, “The Ovation system is designed to overcome the limitations of currently available stent grafts, and our experience with the system in both the clinical trial and in everyday use is encouraging. I would like to thank all the sites who were involved in this important study. Furthermore, I am grateful to my co-authors, whose help on this article was instrumental.” Dr. Mehta, who is the lead author of the article, serves as Director of Endovascular Services at the Vascular Institute for Health & Disease in Albany, New York.

The US Food and Drug Administration approved the low-profile Ovation stent graft system for endovascular aneurysm repair (EVAR) in October 2012. In December 2012, the FDA approved the Ovation Prime system. The Ovation system features a 14-F outer diameter catheter and polymer-filled sealing ring technology that enables on-label treatment of a broad patient population.

TriVascular stated that the prospective, multicenter, single-arm Ovation trial enrolled 161 patients at 36 sites in the United States, Germany, and Chile. Approximately 40% of the patients had complex anatomies, with proximal necks shorter than 10 mm, distal access vessels smaller than 6 mm, or, in some patients, both.

In the study, the method of vessel access was left to the discretion of the physician; 43% (n = 69) of the patients were treated using a percutaneous vessel access technique. The FDA approval recognizes both cutdown and percutaneous vessel access as on-label access techniques for the Ovation system.

The primary safety endpoint of the study was the incidence of major adverse events through 30 days, as adjudicated by an independent Clinical Events Committee (CEC). The 30-day rate of major adverse events was 2.5%, with no device-related major adverse events based on CEC-adjudicated data through 1 year. There were also no reported aneurysm ruptures and no conversions from EVAR to open repair. The imaging core laboratory reported 0% type I and type III endoleaks and 0% migration, reported TriVascular.