Phase II Study Commences for Terumo's Anaconda Stent Graft System
June 19, 2009—The Arizona Heart Institute in Phoenix announced that Julio Rodriguez-Lopez, MD, performed the first procedure in the phase II study of the Vascutek Anaconda stent graft system (Terumo Cardiovascular Systems, Ann Arbor, MI) for the endovascular treatment of abdominal aortic aneurysms (AAAs). Dr. Rodriguez-Lopez is the study's national principal investigator. The objective of the phase II study, conducted under an investigational device exemption, is to assess the safety and efficacy of the Anaconda system in patients presenting with AAAs when compared to historical open-surgical repair. The study is expected to enroll a total of 180 patients at 20 sites in the United States.
"The Anaconda stent graft system has the potential to treat patients with infrarenal AAAs," commented Dr. 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 AAAs."