Firehawk® Receives Regulatory Approval in South Korea
Seoul, South Korea – On January 24, Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®"), in-house developed by Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®"), received the regulatory approval from the Ministry of Food and Drug Safety ("MFDS") of South Korea.
The drug-eluting stent ("DES") is classified as the Type IV high-risk product, which is the priority of the MFDS' oversight and watch during the procedure of pre-market technical approval and post-launch supervision. For the pre-market approval procedure of DES, MFDS has two professional inspector teams to assess the safety and efficacy of the drug and the device/stent respectively. MicroPort® provided a large amount of testing data of Firehawk®, such as its pre-clinical data, clinical data, and documents of production technology control, to prove Firehawk®'s safety and efficacy and to show it complies with relevant regulations of South Korea, and therefore eventually obtained the approval from the MFDS and received the registration certificate. In October 2016, Firehawk® was granted the Korea Good Manufacturing Practice ("KGMP") certificate from the MFDS, which fully demonstrated that both of MicroPort®'s product quality and its quality management system comply with South Korea's regulations.
The revolutionary third-generation DES 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"). As the world's lowest drug dosage stent, Firehawk® combines the merits of the bare metal stent and DES. It adopts unique in-groove abluminal coating design and target-eluting technique, which allow Firehawk® to achieve the same clinical efficacy with significantly low drug loading, benefiting vascular early healing.
In 2014, MicroPort®'s JIVE PTCA Balloon Catheter received the registration certificate in South Korea. Thus, Firehawk®'s regulatory approval will diversify MicroPort®'s product offerings in the South Korea market, paving the way for the company to further expand the local market.
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