Enrollment Completed for Phase I Trial of Bolton's Treovance EVAR Device

November 8, 2011—Bolton Medical (Sunrise, FL) has completed enrollment in phase I of BENEFIT (Bolton Medical Abdominal Stent Graft Trial with Treovance), an evaluation of the safety and efficacy of the company's Treovance abdominal stent graft with Navitel delivery system for use in endovascular aortic repair of abdominal aortic aneurysms. Physicians at six hospitals in the United States have enrolled 30 patients during phase I. Edward Woo, MD, and Ronald Fairman, MD, performed the final case at the University of Pennsylvania Medical Center.

Dr. Fairman commented on treating the final patient, “Given the fact that this woman's anatomy did not qualify for any of the commercially available stent grafts, being able to treat her with a Treovance graft was incredibly meaningful, and I could not be more pleased with the results.”

Dr. Woo added, “The Bolton Treovance phase I trial has been completed, and I have been extremely happy with the performance of the device. It has handled difficult aortic anatomy with excellent results, and I look forward to phase II.”

According to Bolton Medical, the Treovance abdominal stent graft features a flexible design, multiple fixation points, and a wide range of sizes. The low-profile Navitel delivery system is equipped with a detachable sheath and allows for controlled or rapid deployment of the Treovance device. The company is preparing for a pivotal phase II trial in 2012.