Bolton Medical announced that it has enrolled the first patient in its ADVANCE clinical trial to study the safety and performance of the Treovance abdominal stent-graft with Navitel delivery system. The case was performed, on 30 March 2011, by Vicente Riambau, chief of Vascular Surgery at the Hospital Clinic, Barcelona, Spain.
Treovance is offered with the Navitel delivery system, an intuitive low profile system with a mechanical advantage and a completely detachable sheath assembly. Navitel also includes the reliable proximal clasping system of Bolton Medical’s Relay thoracic stent-graft providing accurate deployment.
“The Treovance abdominal stent-graft performed very well,” said Vicente Riambau, “The stent-graft is highly conformable and offers superior fixation through suprarenal barbs and uniquely designed infrarenal barbs.” Regarding the delivery system, Riambau stated, “The low profile Navitel delivery system offers deployment precision due to its proximal stent clasping. The introducer sheath is detachable, offering significant clinical benefits such as less access vessel trauma and the ability to perform a percutaneous approach.”
The primary objective of the ADVANCE study is to assess the safety and performance of the device in subjects with infrarenal aortic aneurysms. Results of this study will support CE marking. Thirty patients will be enrolled at five institutions located in Germany, Italy, The Netherlands and Spain.
According to Bolton Medical, enrolment of the US clinical trial for Treovance is expected to start in May 2011. In the USA the study will be called BENEFIT.