Terumo has planned to release Misago RX in the U.S. Misago® is a peripheral self-expanding stent system consisting of a rapid exchange delivery catheter and a pre-mounted stent made of nitinol.
The bare stent is made of nitinol, a common shape memory alloy used for such applications. Using a thumbwheel, the stent is deployed, casting away the need for other delivery devices.
The stent has shown to be easily positioned across different lesions because of its high flexibility and maintains strength over considerable time periods.
FDA approval was based on submission of one-year data from the Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY). The study findings indicate a low potential for stent fracture, simplified delivery system and 88.6% freedom from target lesion revascularization.
Dr. John Fritz Angle, Principal Investigator for the U.S. clinical trial said, "The MISAGO stent has a flexible design and good radial force that we found performed well in the superficial femoral artery. Peripheral artery disease can have devastating consequences but we believe the MISAGO stent offers a durable treatment option for superficial femoral artery disease."