SANTA ROSA -- TriVascular, maker of stent grafts for endovascular aneurysm repair (EVAR), is marching across Europe with its first product. The Ovation stent graft system was approved for sale overseas last year.
The company has now launched a post-market study to evaluate the treatment of abdominal aortic aneurysms in the real-world setting of routine clinical practice.
Clinical studies done during the regulatory process tend to be structured, with participants selected to represent certain questions that need to be answered prior to approval, said TriVascular spokesman Vivek Jayaraman.
“Although studies have proven that our technology really does improve the lives of patients, there is always the question of how it will fit into the day to day operations of a clinic, where anyone may walk through the door,” he said.
The study, announced at the prestigious Charing Cross International Symposium in the UK, will involve 500 patients at 30 sites. The patients will be followed for five years and the performance of the stent graft carefully noted.
“The study will also be a great way to introduce the technology to a wider geographical area, including Britain, the Netherlands, Austria, Italy, France and Spain,” said Mr. Jayaraman.
“We are excited to partner with many of the leading clinicians in Europe to enhance the body of clinical data supporting Ovation,” said Michael Chobotov, president and CEO of TriVascular.
The Ovation is the lowest-profile commercially available device for the treatment of abdominal aortic aneurysms. It is designed to significantly expand the pool of treatable patients by addressing a wider range of diseased anatomy.
Not yet available in the U.S., the Ovation recently closed enrollment for its pivotal trial with the FDA.
TriVascular employs about 300 in its Santa Rosa Headquarters.
For more information, visit www.trivasucular.com.