Terumo Medical, a US based subsidiary of Terumo Corporation, has intitiated patient enrollment in the Occlusive/stenotic peripheral artery revascularization study (OSPREY), to evaluate the safety and efficacy of Misago peripheral self-expanding stent system for use in the superficial femoral artery (SFA).
The Misago stent system consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter system and has three radiopaque markers located on each end of the stent to help ensure accurate placement in the lesion.
The OSPREY trial is referred to as ‘Medical Device Collaborative Consultation and Review of Premarketing Applications’ under the larger Harmonization by Doing (HBD) initiative and will enroll patients in the US and Japan also.
In the US, 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 under which 50 patients will receive the MISAGO Stent System and 50 patients will receive percutaneous transluminal angioplasty (PTA).
Terumo Medical president and CEO Juichi Jim Takeuchi said that they are proud of the MISAGO Stent System as their first PMA medical device and look forward to continuing to enroll patients into the OSPREY trial to bring this innovative peripheral artery disease treatment to the US market.