October 1, 2010 – The Bradenton Cardiology Center is the first clinic in the United States to implant a peripheral self-expanding stent as part of the OSPREY study. The trial, which is evaluating the safety and efficacy of Terumo’s Misago stent system in the superficial femoral artery (SFA), will simultaneously enroll patients in the United States and Japan.
OSPREY is one of two trials piloting the Harmonization by Doing (HBD) initiative, which is intended to shorten the gap between product approvals in both countries. The pilot program is a cooperative effort led by the U.S. Food and Drug Administration, the MHLW-PMDA (Japan’s regulatory bodies) and Terumo.
“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, M.D., 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 United States, 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 patients receiving percutaneous transluminal angioplasty (PTA).
The system 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 design distributes the dynamic superficial femoral artery stress loads throughout the stent’s struts, providing flexibility and durability against bending, compression and torsion. It also features the first rapid-exchange (RX) delivery catheter for use in the SFA.
The Misago stent system has been available in Europe since November 2007.
For more information: www.terumomedical.com