Terumo Launches Misago RX Self-Expanding Peripheral Stent in United States

June 18, 2015—Terumo Interventional Systems announced the United States launch of the Misago RX self-expanding peripheral stent, which received US Food and Drug Administration (FDA) premarket approval in May. Terumo is introducing the device at the Society for Vascular Surgery’s 2015 Vascular Annual Meeting, being held June 17–20 in Chicago, Illinois. The Misago stent has been available outside of the United States since 2008.

Terumo advised that the Misago stent is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA), and/or proximal popliteal artery with reference vessel diameters ranging from 4 mm to 7 mm and lesion lengths up to 150 mm. The Misago stent system consists of a nitinol stent premounted on the distal portion of a rapid-exchange delivery catheter.

FDA approval was based on submission of 1-year data from the OSPREY (Occlusive/Stenotic Peripheral Artery Revascularization Study) trial. OSPREY is a single-arm, multicenter, nonrandomized prospective clinical trial for the treatment of atherosclerotic stenosis and occlusions of the SFA. As one of the first Harmonization by Doing initiatives between the United States and Japan, the OSPREY study included patients enrolled in the United States, Japan, Taiwan, and Korea.

In the company’s press release, Takao Ohki, MD, chief primary investigator for the OSPREY international trial, commented, “The lack of differences in outcomes among the patients studied supports the validity of multinational trials, which will streamline approvals in different nations and maximize resources while reducing costs. I can foresee future trials [that] build upon our harmonization study design.”

On June 17, John Fritz Angle, MD, principal investigator for the United States clinical trial, presented the results of the OSPREY study at the Vascular Annual Meeting. Dr. Angle commented, “The Misago stent has a flexible design and good radial force that we found performed well in the SFA. Peripheral artery disease can have devastating consequences, but we believe the Misago stent offers a durable treatment option for SFA disease.”

Terumo reported that the OSPREY study demonstrated the device’s flexible, durable design offers a low potential for stent fracture, with a 0.9% incidence of stent fracture per stent at 12 months postprocedure. Additionally, a simplified thumbwheel system allows for precision deployment by a single operator at the lesion site. Physicians in the OSPREY study reported 100% success in delivering the Misago device to the lesion site. The trial also showed sustained patency of 82.9% (peak systolic velocity ratio ≤ 2.4) and an 88.6% freedom from target lesion revascularization, both as measured at 1 year using Kaplan-Meier analysis, reported Terumo.