Brasilia, Brazil - Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®"), the third-generation drug eluting stent ("DES") in-house developed by Shanghai MicroPort Medical (Group) Co (MicroPort®), was approved for market launch by the National Health Surveillance Agency (in Portuguese, Agência Nacional de Vigilância Sanitária - ANVISA), a regulatory body of the Brazilian government, on June 13. This is the second market approval Firehawk® gains in South America, following that in Peru, allowing the device to benefit more patients in the region.
Firehawk® is MicroPort®'s new generation product used for the treatment of coronary artery stenosis and occlusion, following Firebird® Rapamycin-Eluting Coronary Stent and Firebird2® Rapamycin-Eluting Coronary CoCr Stent. It is the world's first and only target eluting stent ("TES"), adopting TARGET Eluting Technique to achieve free redundancy. Its 3D printing technology enables groove filling, which means that the absorbable drug coating is filled in the groove while the other area of the stent has metal surface. Such unique technology makes Firehawk® combine the merits of bare metal stents and DES.
Firehawk® received the registration certificate from China Food and Drug Administration and the CE Mark approval from the European Notified Body in recent years, and was approved for market launch in countries like Thailand, the Philippines, and Indonesia. As it is permitted to be launched in Brazil, MicroPort® will further expand its overseas market.
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