Surgeons from Arizona Heart Institute performed the first procedure in the US Anaconda phase II study using the Vascutek Anaconda Stent Graft System, an investigational, minimally invasive treatment for abdominal aortic aneurysm.
Leading the study efforts in the US is Julio Rodriguez-Lopez, vascular surgeon, Arizona Heart Institute and Arizona Heart Hospital, and national principal investigator. “The Anaconda Stent Graft System has the potential to treat patients with infrarenal abdominal aortic aneurysms,” said Rodriguez. “In commercial use outside the US phase II study, this stent graft has been shown to be flexible and repositionable. These are important features when treating patients with infrarenal abdominal aortic aneurysms,” continued Rodriguez.
“Experience with the device, which has been used commercially in nearly 4,000 patients in Europe, has been very positive,” said Donald B Reid, fellow of the Royal College of Surgeons, consultant vascular surgeon, and chairman of Vascular Surgery with Wishaw General Hospital and University of Glasgow, Scotland, UK, who attended the procedure at Arizona Heart Hospital.
The objective of the Vascutek Anaconda Stent Graft System Phase II IDE Study (G030036) is to assess the safety and efficacy of the Anaconda Stent Graft System in patients presenting with abdominal aortic aneurysm, when compared to historical open surgical repair. The study, which is sponsored by Terumo Cardiovascular Systems, is expected to enroll a total of 180 patients at 20 US sites. The device is manufactured by Vascutek, a Terumo Company located near Glasgow, Scotland.