Terumo Interventional Systems has introduced a self-expanding peripheral stent called MISAGO RX in US. It is a device 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.
“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,” said Chris Pearson, Vice-president, Marketing, Terumo Interventional Systems.
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-centre 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.
Important Safety Information
Do not use this device in patients who exhibit angiographic evidence of severe thrombus in the target vessel or lesion site before/after undergoing Percutaneous Transluminal Angioplasty (PTA) procedure, patients with contraindication to antiplatelet and/or anticoagulation therapy, patients who are judged to have a lesion that prevents proper placement or deployment of the stent, a lesion that is within an aneurysm or an aneurysm with a proximal or distal segment to the lesion, a lesion through which a guide wire cannot pass. This device should only be used by a physician who is familiar with, and well trained in, Percutaneous Transluminal Angioplasty (PTA) techniques and stent implantation.