Terumo Cardiovascular Systems Initiates U.S. Clinical Trial for Anaconda™ AAA Stent Graft System
Ann Arbor, MICHIGAN — July 21, 2009 — 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 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.
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.
Terumo Cardiovascular Systems Corporation manufactures and markets medical devices for the global cardiac surgery market and is the U.S. distributor for Vascutek® Vascular Grafts. The company is headquartered in Ann Arbor, Michigan with manufacturing operations in Ann Arbor; Elkton, Maryland; and Ashland, Massachusetts. It is one of several subsidiaries of Terumo Corporation of Japan that is focused exclusively on cardiac and vascular specialties, including Terumo Heart Inc., developer of a ventricular assist device and Vascutek Ltd., a global leader in the design and manufacture of vascular grafts. For more information, visit www.terumo-cvs.com.
Terumo Corporation is a premier global medical device company with annual sales of more than three billion dollars for the year ending March 31, 2009. Founded in 1921, the company develops, manufactures and distributes world-class medical devices for use in cardiothoracic surgery, interventional procedures, transfusion medicine, and needle and syringe products. For more information, visit www.terumo.co.jp/English/index.html.