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Terumo Completes U.S. Patient Enrollment in the OSPREY Trial to Evaluate the MISAGO Self-expanding Stent
Date:7/11/2012

SOMERSET, N.J., July 11, 2012 /PRNewswire/ -- Terumo Interventional Systems, a strategic business unit of Terumo Medical Corporation, a U.S. subsidiary of Terumo Corporation, today announced the completion of U.S. patient enrollment in the Occlusive/Stenotic Peripheral Artery REvascularization StudY (OSPREY) designed to evaluate the safety and effectiveness of the MISAGO™ Self-expanding Stent System.  OSPREY is a single-arm, multi-center, non-randomized prospective clinical trial for the treatment of atherosclerotic stenoses and occlusions of the superficial femoral artery that included 200 patients in 31 centers in the U.S. and 100 patients in seven centers in Japan.

(Photo: http://photos.prnewswire.com/prnh/20120711/NY37622 )

A unique feature of this landmark study is that it simultaneously enrolled patients in the U.S. and Japan as part of the larger Harmonization by Doing (HBD) pilot program, a cooperative effort led by the U.S. Food & Drug Administration, the MHLW/PMDA (Japan's regulatory body), Terumo Corporation, based in Tokyo, Japan, and Terumo Medical Corporation, based in Somerset, New Jersey.  The HBD initiative is intended to shorten the gap between product approvals in these two significant world healthcare markets. 

"OSPREY is Terumo Medical Corporation's first U.S. clinical trial for a premarket approval (PMA) device and we are exceptionally pleased with its progress.  Terumo is greatly appreciative of the tremendous support given by our U.S. clinical investigators, which helped us meet the critical enrollment goal in this landmark HBD initiative," said James Rushworth, President of Terumo Interventional Systems and Onset Medical Corporation. "The OSPREY trial and the MISAGO Stent truly speak to our three strategic pillars of introducing innovative technologies that create Clinical, Economic, and Quality of Life
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SOURCE Terumo Interventional Systems
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