Terumo Completes U.S. Patient Enrollment in the OSPREY Trial to Evaluate the MISAGO Self-expanding Stent
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.
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 Benefits."
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.
"Peripheral vascular disease is a leading cause of disability in the U.S., affecting between 8 and 12 million Americans. It is critical that physicians, and their patients, have faster access to the latest technologies in order to maximize treatment options," said J. Fritz Angle, MD, Professor of Radiology, University of Virginia, and U.S. Principal Investigator in the OSPREY trial. "I look forward to analyzing and discussing the OSPREY data with all of the trial investigators. The international experience and testing efficiencies obtained from our collective participation in this HBD initiative could have a dramatic effect on the way important medical devices reach the market in the future."