One-year outcomes from the TriVascular Ovation global pivotal study were published in the Journal of Vascular Surgery on 26 August 2013. The paper concluded that “one-year outcomes with the Ovation stent graft are promising with excellent demonstrated safety and effectiveness in patients with abdominal aortic aneurysms. These results were similarly remarkable in patients with challenging anatomical characteristics who would be ineligible for treatment with other approved stent grafts.”
Delivered through a 14F outer diameter catheter, the Ovation stent graft system is the lowest profile FDA-approved device for EVAR. Conventional EVAR systems are significantly larger, ranging from 18 to 24 French outer diameters. The Ovation system’s low profile, combined with a unique polymer-filled sealing ring technology, enables on-label treatment of a broader patient population than any other approved EVAR system. In the Ovation pivotal study, nearly 40% of the patients treated had complex anatomies, with proximal necks shorter than 10mm, distal access vessels smaller than 6mm, or, in some patients, both. Prior to the TriVascular Ovation pivotal study, these patients did not have an on-label EVAR option due to the limited indications for use of other FDA-approved systems.
“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,” commented Manish Mehta, director of Endovascular Services at the Vascular Institute for Health & Disease in Albany, New York, who is the lead author on the publication. “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.”
“TriVascular is deeply committed to clinical research. Our current pre-market studies and post-market registries are actively studying nearly 700 patients around the world. We are grateful for the strong support from our clinical partners, without whom our clinical trial and subsequent data publication would not be possible,” said Christopher G Chavez, chairman, CEO and president of TriVascular. “The compelling, peer-reviewed clinical results are excellent evidence that the Ovation system provides a proven EVAR solution physicians can offer to more patients.”
The prospective, multicentre, single-arm trial included 36 sites from the USA, Germany and Chile, with a total of 161 patients enrolled. 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 major adverse event rate was 2.5%, with no device-related major adverse events based on CEC adjudicated data through one year. The Ovation study also reported no aneurysm ruptures and no conversations from EVAR to open repair. The imaging core laboratory reported 0% type I and type III endoleaks and 0% migration. Forty three per cent (n=69) of the patients in the study were treated using a percutaneous vessel access technique, by far the highest rate of any clinical trial for a new EVAR device.
The method of vessel access was left to the discretion of the physician, and the resulting FDA approval recognises both cut-down and percutaneous vessel access as on-label access techniques for the Ovation system.
Worldwide, nearly 2,500 patients have been treated with Ovation and Ovation Prime systems, with over 500 of these patients treated in the United States. In addition to the premarket clinical trial, TriVascular has enrolled over 400 patients in a European Post Market Registry. The US FDA approved the Ovation system in October 2012 and subsequently approved the Ovation Prime system in December 2012. Today, Ovation and Ovation Prime systems are marketed in over 30 countries across the world.