TriVascular announced at the European Society for Vascular Surgery annual meeting in Amsterdam, CE Mark approval for the Ovation abdominal stent graft. The 14F OD system offers the lowest profile of any commercially available device, and is designed to expand the patient population suitable for endovascular aortic repair (EVAR) by addressing a wider range of diseased anatomies.
“The Ovation System is a novel technology that optimises the two most important requirements for EVAR, fixation and seal,” said Michael Dake, MD.
The Ovation abdominal stent graft system has been implanted in approximately 50 patients across three continents. In Chile, the trial evaluated the safety and performance of the device and was led by Francisco Valdes. In Germany, Thomas Nolte led the safety and performance trial. In the US, the pivotal study is evaluating the safety and effectiveness of the Ovation abdominal stent graft system and is being led by Manish Mehta. The Ovation Abdominal Stent Graft System is an investigational device and currently not approved for sale.