Firehawk^® 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.