Shanghai, China – On March 22, Vertebral Artery Rapamycin Target Eluting Stent System of MicroPort NeuroTech (Shanghai) Co., Ltd. ("MicroPort® NeuroTech"), a wholly owned subsidiary of Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®"), was granted to enter the special Green-Path by China Food and Drug Administration ("CFDA"), which is rapid-track of review and approval procedure for innovative medical devices. Up to date, a total of 12 products in-house developed by MicroPort® and its subsidiaries have entered Green-Path.
In the cerebrovascular system, vertebral artery is the part most likely to have stenosis other than carotid artery bifurcation. Traditional drugs have limited effect in treating vertebral artery stenosis and are likely to increase the risk of bleeding. On the other hand, open surgery also has its shortcomings in treating the disease such as complex procedure and big trauma. As an emerging technology to treat vertebral artery stenosis, interventional treatment can significantly improve the hemodynamics of narrow vertebral artery, with less complications and good clinical efficacy, which makes it the safest and most effective treatment. However, there is no stent specially designed for the treatment of vertebral artery stenosis, so physicians have to use coronary drug-eluting stents or intracranial artery stents to treat vertebral artery stenosis.
Vertebral Artery Rapamycin Target Eluting Stent System is the world's first drug-eluting stent indicated for the treatment of vertebral artery stenosis. The device design conforms to the anatomical features of vertebral artery, and it has excellent crossability and radial strength. The product adopts target-eluting technology to release the drug from polymer coating to vascular walls with control by drug-eluting technology, which will help to reduce the occurrence rate of vascular restenosis without impacting on the process of vessel endothelialization, ensuring its safety and efficacy at the same time. Vertebral Artery Rapamycin Target Eluting Stent System achieved good clinical trial outcome with significantly lower occurrence rate of vascular restenosis compared to other devices physicians used to treat vertebral artery stenosis.
MicroPort® NeuroTech's Tubridge® Vascular Reconstruction Device ("Tubridge®") was granted CFDA Green-Path in 2015 and gained CFDA approval in March. It is expected that the CFDA Green-Path of Vertebral Artery Rapamycin Target Eluting Stent System will also shorten its approval time to benefit more patients.
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