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Terumo To Simultaneously Evaluate Misago Self-Expanding Stent System in the United States and Japan
Date:5/12/2010

six patients enrolled in Japan, which received regulatory approval to begin the trial last year.  The first U.S. enrollments are expected in June 2010.  The U.S. principal investigator is J. Fritz Angle, MD, Associate Professor of Radiology, University of Virginia.

"Peripheral vascular disease management continues to be a major clinical problem," said Dr. Angle.  "We need better tools to improve revascularization of femoral-popliteal vessels.  I applaud Terumo's efforts to advance this field."

The MISAGO Self-expanding Stent consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter system.  The stent has three radiopaque markers located on each end of the stent to help ensure accurate placement in the lesion.  The stent is currently available for sale in Europe.

"We are eager to move forward with the first harmonized clinical trial in the U.S. and Japan," said Juichi (Jim) Takeuchi, President and CEO, Terumo Medical Corporation.  "We are not only proud of the MISAGO Stent, but also of Terumo's selection to participate in this precedent-setting international collaborative effort between regulators, industry, clinical researchers, patients, and academia.  We look forward to initiating our first PMA clinical trial in the United States and to bringing innovative new interventional technology to market to improve patients' quality of life."  

For more information, customers can contact Tamera Barry-Lawal, Terumo Project Manager, at 732.302.4955.

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SOURCE Terumo Interventional Systems
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