Firehawk® Receives Regulatory Approval in Mexico

Mexico City, Mexico – On January 18, Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®"), the third-generation drug-eluting stent ("DES") in-house developed by Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®"), received the regulatory approval from the health authority of the Mexican government - the Federal Commission for the Protection against Sanitary Risk (in Spanish, Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). It is another registration certificate Firehawk® received in the South America markets following those in Peru, Brazil and Argentina.
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.
Before Firehawk®'s regulatory approval in Mexico, another product of MicroPort® - FOXTROT™ PRO Balloon Dilation Catheter had gained the registration certificate from the COFEPRIS. With them, MicroPort® will provide better and more comprehensive medical solutions for South American patients by offering stent and balloon products used in PCI in the Mexico market, which will also lay a solid foundation for the company to further expand the local market.