Launch in US of Misago RX Self-expanding Peripheral Stent for treatment of peripheral artery disease - Misago Interventional Systems

Terumo Interventional Systems will introduce the Misago RX Self-expanding Peripheral Stent to the U.S. market at the 2015 Society for Vascular Surgery Annual Meeting (SVS), June 17-20, Chicago. The stent has been received pre-market approval by the FDA. The Misago stent system consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter. Designed and developed in Japan, it is now available to treat patients in the U.S. with peripheral artery disease in the superficial femoral artery (SFA) and/or proximal popliteal artery. 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.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.