Terumo Cardiovascular Systems Initiates U.S. Clinical Trial for Anaconda(TM) AAA Stent Gr...( ANN ARBOR Mich. July 24 /- Teru...),Health

ANN ARBOR, Mich., July 24 /PRNewswire/ -- Terumo Cardiovascular Systems (Terumo CVS) announced that it has initiated a Phase II Clinical Trial for the Anaconda(TM) AAA (Abdominal Aortic Aneurysm) Stent Graft System in the U.S. The Anaconda system is manufactured by Scotland-based Terumo subsidiary Vascutek Ltd. The first U.S. implant was performed on June 8th at Arizona Heart Hospital by the principal investigator, Julio Rodriguez-Lopez, M.D.

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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 U.S. where it has been implanted in nearly 4000 patients. It received CE Mark in Europe in April 2005.

According to the Society of Vascular Surgery, physicians diagnose approximately 200,000 people with AAAs in the U.S. annually. Treatment options include medical management of co-morbidities such as hypertension or pulmonary disease, open surgical repair and endovascular repair. Endovascular repair using commercially available devices has been associated with shorter recovery times, reduced hospital stay, and other benefits.