Terumo Completes U.S. Enrollment in OSPREY Trial to Evaluate the Misago Self-Expanding Stent

Unique study is part of FDA's "Harmonization by doing" program to streamline product approval process through unprecedented international regulatory cooperation

 

July 12, 2012

July 12, 2012 — Terumo Interventional Systems, a strategic business unit of Terumo Medical Corporation, a U.S. subsidiary of Terumo Corporation, announced the completion of U.S. patient enrollment in the Occlusive/StenoticPeripheral 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 United States and 100 patients in seven centers in Japan.

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

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.

The first U.S. patient implant in the OSPREY trial occurred in September 2010. The primary endpoints of the U.S. arm of the OSPREY 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.

For more information: www.terumois.com

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