Trial Enrollment Begins for Bolton Medical's Treovance AAA Stent Graft

June 15, 2011—Bolton Medical, Inc. (Sunrise, FL) announced that it has begun its BENEFIT (Bolton Medical Abdominal Stent Graft Trial with Treovance) clinical study, with the initial case performed by Michael C. Stoner, MD, at East Carolina University/East Carolina Heart Institute in Greenville, North Carolina. Edward Y. Woo, MD, performed the trial's second case at the University of Pennsylvania in Philadelphia. 


According to the company, the primary objective of the BENEFIT clinical study is to assess the safety and performance of the Treovance abdominal stent graft in patients with infrarenal aortic aneurysms. Results of this study will support the company's submissions to the US Food and Drug Administration. Phase 1 of the study includes 30 patients enrolled at seven institutions located throughout the United States. In Europe, the ADVANCE study of the Treovance has been ongoing since March 2011.



“The Treovance abdominal stent graft system performed very well,” commented Dr. Stoner. “The active fixation barbs coupled with the leg-locking mechanisms on the stent graft address durability concerns, particularly for patients with challenging anatomies." Regarding the delivery system, Dr. Stoner stated, "The delivery and deployment of the Treovance stent graft are quite intuitive, and I was very satisfied with the ability to fine-tune the proximal stent."

Commenting on his procedure, Dr. Woo stated, "The device worked great. This was not a straightforward case, but it handled the anatomy very easily. This will definitely be an important next-generation device."



Bolton Medical advised that the Treovance key features include a three-piece, adaptable system that can accommodate a wide-range of anatomies; active fixation through suprarenal and infrarenal barbs allowing for proximal and supplemental fixation in highly angulated necks; a highly flexible design, making it conformable even in difficult anatomies; and the low-profile Navitel delivery system with a mechanical advantage and a completely detachable sheath assembly. The Navitel delivery system also includes the proximal clasping system of the Relay thoracic stent graft for simple, accurate deployment.