Terumo Medical Corporation, a U.S.-based subsidiary of Terumo Corporation, today announced the first U.S. patient implant in the Occlusive/Stenotic Peripheral artery REvascularization StudY (OSPREY), which will evaluate the safety and efficacy of its MISAGO Peripheral Self-expanding Stent System for use in the superficial femoral artery (SFA). The procedure was performed at the Bradenton Cardiology Center in Bradenton, Florida.
A unique feature of the OSPREY 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, the OSPREY 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. The pilot program is a cooperative effort led by the U.S. Food & Drug Administration, the MHLW-PMDA (Japan's regulatory bodies), Terumo Corporation based in Tokyo, Japan, and Terumo Medical Corporation, a U.S.-based subsidiary of Terumo Corporation.
"We are pleased to be the first U.S. center to kick off this exciting international trial to evaluate the safety and efficacy of the MISAGO Stent System for treating patients with peripheral artery disease," said Srinivas Iyengar, MD, primary operator and site Principal Investigator for the OSPREY trial. "This is a unique and exciting opportunity for myself and the Bradenton Cardiology Center to be a part of the first international initiative to streamline the regulatory process to facilitate future medical device approvals between 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 System and 50 pat
|Contact: Robert Murphy|
The Storch Murphy Group