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Bolton Medical begins Phase II US clinical trial of Treovance abdominal stent-graft system

Bolton Medical, a medical device manufacturer, has initiated its Phase II US clinical trial to study the safety and effectiveness of the Treovance abdominal stent-graft with Navitel delivery system.

The first two cases were performed on 25 November 2013 by Carolina Vascular, Mission Hospital, Asheville vascular surgeons Dr John Henretta and Dr Mike Douglas.

Dr Henretta noted both cases went really well.

"It’s a nice device that allows for precise placement. Its delivery system is easy to advance through the iliac anatomy, and the material is non-porous. I feel secure about the device’s long term-durability and we look forward to enrolling more patients," Dr Henretta added.

The third case was performed the same week on 27 November 2013 by University of Massachusetts Medical Center, Worcester vascular surgeon Dr Andres Schanzer.

The primary objective of the clinical study is to assess the safety and effectiveness of the Treovance abdominal stent-graft in subjects with infrarenal aortic aneurysms.

Results of this study will support approval of the product in the US. Phase II of the study will include 150 patients enrolled at 30 institutions located throughout the US.

The Treovance abdominal stent-graft offers many key features which include: 1. a three-piece, adaptable system that can accommodate a wide-range of anatomies, 2. active fixation through suprarenal and infrarenal barbs permitting proximal and supplemental fixation in highly angulated necks, and, 3. a highly flexible design, conformable even in difficult anatomies.

The Treovance abdominal stent-graft is offered with the Navitel delivery system, an intuitive low profile system featuring mechanical advantage and a completely detachable sheath assembly.

The Navitel delivery system also includes the reliable proximal clasping system of Bolton Medical’s Relay Thoracic stent-graft, allowing for accurate deployment.