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

ence between FDA and MHLW-PMDA (Japan's regulatory bodies).  The learning obtained in the "proof of concept" trials will assist both regulatory bodies in streamlining the clinical trial process for faster approvals in both countries, as well as promote the idea of global trials for purposes of collecting better data.  In this pilot HBD approach, the products will be submitted for review and approval at the same time.

"I believe this approach to shorten the time for new product approvals between the U.S. and Japan is critical and exciting," said Takao Ohki, MD, Chairman and Professor, Department of Surgery, Jikei University School of Medicine, Division of Vascular Surgery, and the global principal investigator of the OSPREY trial.  "This innovative movement could dramatically solve the current device lag issue between our countries."

In the U.S., OSPREY is a single-arm, multi-center, non-randomized prospective clinical trial for the treatment of atherosclerotic stenoses and occlusions of the SFA.  In Japan, there are two arms of the study, 50 patients receiving the MISAGO Stent and 50 patients receiving percutaneous transluminal angioplasty (PTA).  

The primary endpoints of the U.S. study are:

  • Primary stent patency rate at one year as confirmed by duplex ultrasound or angiography.
  • Freedom from major adverse events within 30 days of the procedure, which would result in target lesion revascularization, amputation of the treated limb or death.

The study will include up to 350 patients, a maximum of 250 patients in up to 30 centers in the U.S. and 100 patients in Japan.  There have already been
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SOURCE Terumo Interventional Systems
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