The Ovation registry is evaluating the treatment of abdominal aortic aneurysms in the real-world setting of routine clinical practice. Including the Ovation pre-market clinical trial, over 700 patients have participated in a clinical study with either the Ovation or Ovation Prime stent graft system. The 30-day OVATION post-market study results were presented at the Leipzig Interventional Course (LINC) 2014 on 28 January 2014.
Dierk Scheinert, head of the Department of Medicine, Angiology and Cardiology at Park-Krankenhaus Leipzig, Germany, who serves as the OVATION European principal investigator said: “We have been very pleased with our Ovation experience, both in challenging and more straightforward anatomies. Since our participation in the original CE mark study, we have seen excellent results with the system and it is now a routine part of our treatment protocol for abdominal aortic aneurysms. I look forward to the results of this study, which will allow us to evaluate the Ovation system in routine clinical use.”
The post-market study’s primary endpoint is treatment success, a composite of technical and clinical success at 12 months. Technical success includes successful delivery and deployment of the stent graft. Clinical success includes freedom from aneurysm expansion, aneurysm rupture, type I and III endoleaks, conversion to open repair, stent graft migration, and stent graft occlusion. In the pre-market pivotal trial, at both the one-year and two-year mark, the Ovation system demonstrated 100% freedom from type I and III endoleaks, migration, rupture and conversion to open surgical repair. In addition, the pivotal trial cohort showed no aortic neck growth at either one or two years. Forty eight per cent of the patients in the trial were treated via a percutaneous (PEVAR) vessel access method. Thirty nine percent of the patients treated in the Ovation pivotal study would have been excluded from treatment in previous EVAR trials due to challenging anatomical characteristics. One-year results from the Ovation pre-market trial were published in the Journal of Vascular Surgery in January 2014.
At 14F outside diameter, the Ovation stent graft is the lowest profile, commercially available EVAR system, a press release from the company says. The Ovation system is approved for sale in over 30 countries and, worldwide, over 3,000 patients have been treated with the Ovation or Ovation Prime stent graft systems.