Terumo Interventional Systems has introduced its MISAGO RX self-expanding peripheral stent in the US, which is used to treat patients with peripheral artery disease in the superficial femoral artery (SFA) and proximal popliteal artery.
Designed and developed in Japan, the stent was studied in around 5,000 patients in multiple clinical trials and is available outside the US since 2008.
Terumo Interventional Systems marketing vice-president Chris Pearson said: "We look forward to partnering with the US interventional medical community to bring the benefits of this novel technology, as well as others in the future, to patients in the US."
Terumo received premarket approval (PMA) from the US FDA for the device in May this year.
It was approved based on one-year data from the Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY), which is a single-arm, multi-center and non-randomized prospective clinical trial to treat atherosclerotic stenosis and occlusions of the SFA.
In one of the first Harmonization by Doing (HBD) initiatives between the US and Japan, the trial enrolled patients in the US, Japan, Taiwan and Korea.
The OSPREY study reported sustained patency of 82.9% and 88.6% freedom from target lesion revascularization, as measured at one-year using Kaplan-Meier analysis. In the trial, there was a 0.9% incidence of stent fracture per stent at 12 months post-procedure.
Terumo is showcasing the stent at the 2015 Society for Vascular Surgery Annual Meeting (SVS) in Chicago, which is being held from 17 to 20 June.
Image: The MISAGO RX self-expanding peripheral stent. Photo: courtesy of PRNewswire/ Terumo Medical Corporation.