Enrollment Begins in European Trial of Bolton Medical's Treovance

April 4, 2011—Bolton Medical, Inc. (Sunrise, FL) announced that it has enrolled the first patient in its European ADVANCE clinical trial to study the safety and performance of the company's Treovance abdominal stent graft with the Navitel delivery system.

According to Bolton Medical, the primary objective of the ADVANCE study is to assess the safety and performance of the device in patients with infrarenal aortic aneurysms. Results of this study are intended to support the company's application for CE Mark approval of the device in Europe. The study will include 30 patients enrolled at five institutions located in Germany, Italy, the Netherlands, and Spain. Enrollment of Bolton Medical's United States BENEFIT clinical trial for the Treovance abdominal stent graft is expected to start in May 2011.

"The Treovance abdominal stent graft performed very well," commented Vicente Riambau, MD, who performed the trial's first procedure. “The stent graft is highly conformable and offers superior fixation through suprarenal barbs and uniquely designed infrarenal barbs. 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."