Firehawk® Gains Regulatory Approval in Taiwan

Taibei, China – On January 12, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") received the regulatory approval from Taiwan Food and Drug Administration ("TFDA") for its in-house developed Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®"). It is the first drug-eluting stent in MicroPort® and the whole Chinese mainland that successfully gained the regulatory approval in Taiwan, marking a milestone in the development of MicroPort®'s cardiovascular business segment.
Firehawk® 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.
With the increasing aging population, the incidence rate of coronary disease is constantly growing in Taiwan. According to statistics, there are around 30,000 PCI cases in the Taiwan market annually and the demand for coronary stent is rapidly increasing. After around two years' effort, MicroPort® successfully gained the regulatory approval of Firehawk® in the Taiwan market, signifying a major step forward for the company's market development in Taiwan. With its outstanding performance, it is expected that Firehawk® will provide more ideal cardiovascular treatment for local patients and help enhance the communication between cardiologists from Taiwan and the mainland as well.