Terumo is releasing its Misago RX in the USA, self-expanding peripheral stent for treatment of stenoses and occlusions in the superficial femoral and proximal poplitea arteries. The bare stent is made of nitinol, a common shape memory alloy used for such applications.The stent is deployed using a thumbwheel, so you don’t need an extra set of hands as with some oother delivery devices. Because of its high flexibility, the stent has shown to be easily positioned across different lesions while and maintaining its strength over considerable time periods.The MISAGO stent has been available outside of the U.S. since 2008. It has been studied in more than 5000 patients in numerous clinical trials. The U.S. FDA granted premarket approval (PMA) for the device in May. FDA approval was based on submission of one-year data from the Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY), a single-arm, multi-center, non-randomized prospective clinical trial for the treatment of atherosclerotic stenosis and occlusions of the SFA. In one of the first Harmonization by Doing (HBD) initiatives between the United States and Japan, the study included patients enrolled in the U.S., Japan, Taiwan and Korea.From Terumo:Sustained patency of 82.9% as measured at one-year using Kaplan-Meier analysis (PSVR of less than or equal 2.4).88.6% freedom from target lesion revascularization, as measured at one-year using Kaplan-Meier analysis.About the MISAGO StentThe MISAGO stent is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or occlusions of the SFA and/or proximal popliteal artery with reference vessel diameters ranging from 4 mm to 7 mm and lesion length up to 150 mm. The product will be available for demonstration at the Terumo Booth #610 throughout SVS. For more information visit www.terumois.com.About TerumoTerumo Interventional Systems (TIS), a division of Terumo Medical Corporation, is a market leader in minimally invasive entry site management and lesion access technologies. TIS offers a complete, solution-based product portfolio used in advanced coronary, peripheral endovascular and urological treatments with strategic initiatives in Transradial Access, Complex Coronary Intervention and Critical Limb Ischemia. TIS combines innovative research and development with a deep market understanding to create a pipeline of industry leading devices that deliver clinical value, economic benefit, and enhanced patient outcomes. Terumo Medical Corporation is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with over $5 billion in sales and operations in more than 160 nations.