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

SOMERSET, N.J., May 12 /PRNewswire/ -- Terumo Medical Corporation, a U.S.-based subsidiary of Terumo Corporation, today announced it has received an investigational device exemption (IDE) conditional approval from the U.S. Food & Drug Administration (FDA) for its Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY) in the U.S., which will evaluate the safety and effectiveness of the MISAGO™ Self-expanding Stent System for use in the superficial femoral artery (SFA).  This marks the company's first U.S. clinical trial for a premarket approval (PMA) device.  A unique feature of the clinical trial is that it will simultaneously enroll patients in the U.S. and Japan.  Referred to as  "Medical Device Collaborative Consultation and Review of Premarketing Applications" under the larger "Harmonization by Doing" (HBD) initiative, Terumo's trial was selected as one of two projects to pilot this approach, which is intended to shorten the gap between product approvals in these two significant world healthcare markets.

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HBD is an international effort to develop global clinical trials and address regulatory barriers that may be impediments to timely device approvals.  This process is a cooperative effort to move both Japan and the U.S. toward international regulatory harmonization.  The HBD initiative is a pilot project launched in December 2003 that seeks regulatory converg
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SOURCE Terumo Interventional Systems
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