Firehawk<sup>®</sup> Gains Regulatory Approval in Myanmar
Naypyidaw, Myanmar - Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") received the regulatory approval from Myanmar authority for its in-house developed Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®"). It is the first time for MicroPort® products to gain regulatory approval in Myanmar.
Firehawk® is the result of eight years of research and development of MicroPort® and it is the world's first and only target-eluting stent ("TES"). It is a new-generation drug-eluting stent of MicroPort® for the treatment of coronary artery stenosis or occlusion after Firebird® Rapamycin-Eluting Coronary CoCr Stent System ("Firebird®") and Firebird2® Rapamycin-Eluting Coronary CoCr Stent System ("Firebird2®"). Firehawk® adopts TES Technology platform, and its coating area is only 20% of the stent surface. Firehawk®'s drug is released over 90 days and its polymer is fully absorbed in nine months. Its average metal coverage rate is 14.0-16.1%. Firehawk® is the world's lowest drug dosage stent, with only 1/3 dosage versus similar products while achieving the same efficacy.
Previously, Firehawk® gained CE mark, approval from China Food and Drug Administration and regulatory approval in more than 30 countries including India, Thailand, Indonesia, Brazil, Argentina, and Colombia. The approval of Firehawk® in Myanmar represents a milestone in the development of the local market as well as the market expansion of Firehawk®. In the future, MicroPort® will continue to offer more high quality medical device to the Myanmar market to benefit local patients.
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