The Bradenton (FL) Cardiology Center is the first center in the US to implant the MISAGO Peripheral Self-expanding Stent System as part of the Occlusive/Stenotic Peripheral artery REvascularization StudY (OSPREY), which will evaluate the safety and efficacy of the MISAGO Stent System for use in the superficial femoral artery (SFA).

The OSPREY clinical trial will simultaneously enroll patients in the US 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 the US and Japan. The pilot program is a cooperative effort led by FDA, MHLW-PMDA (Japan’s regulatory bodies), Tokyo-based Terumo Corp (MISAGO’s) manufacturer), and Somerset-NJ-based Terumo Medical Corporation, a subsidiary of Terumo Corporation.

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, 50 patients receiving the MISAGO Stent System and 50 patients receiving percutaneous transluminal angioplasty (PTA).

The primary endpoints of the US 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.

The study will include up to 350 patients—a maximum of 250 patients in up to 30 centers in the US and 100 patients in Japan. Japan received regulatory approval to begin the trial last year and has already started to enroll patients.

The MISAGO 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, thus providing flexibility. The design also protects against bending, compression, and torsion. The MISAGO system features the first rapid-exchange (RX) delivery catheter for use in the SFA.

The MISAGO system has been available in Europe since November 2007. To date, approximately 9,000 femoral-popliteal units have been sold (7,500 patients treated).