TriVascular announced enrolment completion of its Ovation Abdominal Stent Graft System. Thirty six clinical sites, across three countries, participated in the IDE study, which is designed to evaluate the safety and effectiveness of Ovation for use in endovascular aortic repair (EVAR) of abdominal aortic aneurysms.
“The rapid enrolment of the pivotal trial is a testament to physician enthusiasm for Ovation,” said Manish Mehta, associate professor of Surgery at Albany Medical College, director of Endovascular Services for the Vascular Group and principal investigator for the study. “The system is truly innovative and represents a very novel approach to EVAR. Furthermore, the inclusion criteria for the study are broader than those of prior trials, and could serve to expand the pool of patients to whom we can offer a minimally invasive therapy. I am pleased to be involved with this study, and believe Ovation will be a very valuable addition to my clinical practice.”
Ovation received CE mark clearance in August 2010, and was officially launched in Europe in January 2011. At 14F OD, Ovation is the lowest profile commercially available abdominal aortic aneurysm repair device. The innovative, low profile system separates and optimises the two most important elements of EVAR, fixation and seal, and is designed to expand the pool of treatable patients by addressing a wider range of diseased anatomy. In the United States, the Ovation Abdominal Stent Graft System is an investigational device and is not currently available for sale.
“We are thrilled with the rapid, high quality enrolment in our IDE study,” said Michael Chobotov, president and CEO of TriVascular, “Achieving this critical milestone brings us one step closer to regulatory approval in the United States. We are fortunate to enjoy strong partnerships with physicians across the globe, and I am grateful for the trust they have extended to TriVascular as we work together to improve patient care.”