Bolton Medical's Phase II Trial Evaluates Treovance Abdominal Stent Graft System

December 2, 2013—Bolton Medical, Inc. (Sunrise, FL) announced the initiation of its phase II clinical trial in the United States to study the safety and effectiveness of the Treovance abdominal stent graft with Navitel delivery system in patients with infrarenal aortic aneurysms. The phase II study will include 150 patients enrolled at 30 institutions located throughout the United States. Results of this study will support approval of the product in the United States.

Matthew Eagleton, MD, serves as National Principal Investigator for the trial. Dr. Eagleton is a vascular surgeon with the Sydell and Arnold Miller Family Heart & Vascular Institute at the Cleveland Clinic in Cleveland, Ohio.

In Bolton Medical’s press release, Dr. Eagleton commented, “The first phase II Treovance endovascular aneurysm repairs mark an exciting time for Bolton Medical and the investigators involved in this trial. Their successful implantation is a credit to the quality of the device and the teams involved in its development and clinical application. We look forward to many more successful implants and the opportunity to treat patients with a life-threatening disease.”

John Henretta, MD, and Mike Douglas, MD, who are vascular surgeons with Carolina Vascular at Mission Hospital in Asheville, North Carolina, performed the first two cases on November 25. In the company’s press release, Dr. Henretta commented, “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 nonporous. I feel secure about the device's long-term durability and we look forward to enrolling more patients.”

On November 27, the third case in the trial was performed by Andres Schanzer, MD, a vascular surgeon at University of Massachusetts Medical Center in Worcester, Massachusetts.

According to Bolton Medical, the Treovance abdominal stent graft's features include a three-piece, adaptable system that can accommodate a wide range of anatomies; active fixation through suprarenal and infrarenal barbs permitting proximal and supplemental fixation in highly angulated necks; and a highly flexible design, conformable even in difficult anatomies. The Navitel delivery system is a low-profile system featuring a completely detachable sheath assembly. The Navitel system also includes the proximal clasping system of Bolton Medical’s Relay thoracic stent graft that allows for more accurate deployment, stated the company.