June 22, 2009 – Surgeons from Arizona Heart Institute performed the first procedure in the U.S. Anaconda Phase II Study using the Vascutek Anaconda Stent Graft System, an investigational, minimally invasive treatment for abdominal aortic aneurysm (AAA).
Julio Rodriguez-Lopez, M.D., vascular surgeon of Arizona Heart Institute and Arizona Heart Hospital and national principal investigator, leads the study efforts in the U.S. "The Anaconda Stent Graft System has the potential to treat patients with infrarenal AAAs," he said. "In commercial use outside the U.S. phase II study, this stent graft has been shown to be flexible and repositionable.”
Studies report that emergent, open surgical repair of a ruptured aortic aneurysm carries a 25 to 50 percent risk of death; however, less invasive endovascular procedures involving stent grafts offer a lower-risk alternative to open surgical repair and are associated with minimal blood loss, faster recovery, shorter hospital stays and decreased risk of death.
"Experience with the device, which has been used commercially in nearly 4,000 patients in Europe, has been very positive," said Donald B. Reid, M.D., fellow of the Royal College of Surgeons, consultant vascular surgeon, and chairman of vascular surgery with Wishaw General Hospital and University of Glasgow, Scotland, U.K., who attended the procedure at Arizona Heart Hospital.
The objective of the Vascutek Anaconda Stent Graft System Phase II IDE Study is to assess the safety and efficacy of the Anaconda Stent Graft System in patients presenting with AAA, when compared to historical open surgical repair. The study, sponsored by Terumo Cardiovascular Systems, may enroll a total of 180 patients at 20 U.S. sites. Vascutek Ltd. manufactures the device.
For more information: www.azheart.com