SANTA ROSA -- TriVascular Inc. announced enrollment is complete for the U.S. pivotal study 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 enrollment of the pivotal trial is a testament to physician enthusiasm for Ovation, according to Manish Mehta, M.D., professor of surgery at Albany Medical College and director of endovascular services for the firm in charge of the study, Vascular Group, PLLC.
"The system is truly innovative and represents a very novel approach to EVAR," Dr. Mehta said. "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 for European markets in August 2010 and was officially launched on the continent in January. The low-profile system separates and optimizes 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 U.S., the Ovation abdominal stent graft system is an investigational device and not currently available for sale.
"We are thrilled with the rapid, high-quality enrollment in our IDE study," said Michael Chobotov, Ph.D., president and chief executive officer 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’m grateful for the trust they’ve extended to TriVascular as we work together to improve patient care."
TriVascular's initial product offerings are novel endovascular grafts focused on significantly advancing EVAR technology. The Santa Rosa company employs 250 full-time and about 100 part-time workers.