Terumo Cardiovascular Systems (Terumo CVS) announced that it has initiated a Phase II Clinical Trial for the Anaconda AAA (Abdominal Aortic Aneurysm) Stent Graft System in the US. The Anaconda system is manufactured by Terumo subsidiary Vascutek Ltd. The first US implant was performed on June 8th at Arizona Heart Hospital by the principal investigator, Julio Rodriguez-Lopez, M.D.
The objective of the Vascutek Anaconda Stent Graft System Phase II IDE Study (G030036) is to assess the safety and effectiveness of the Anaconda stent graft system in patients presenting with AAA when compared to historical open surgical repair. The Food and Drug Administration (FDA) has given Terumo CVS approval to enroll 180 patients at 20 sites, some of which will be in Canada. The primary endpoint for the study is the successful treatment of the aneurysm twelve months after the implantation of the device. Patients in the study will be followed for a total of five years. The Anaconda system is commercially available outside the US where it has been implanted in nearly 4000 patients. It received CE Mark in Europe in April 2005.