FOXTROT® NC PTCA Balloon Catheter Gains Regulatory Approval in Mexico

Mexico City, Mexico – FOXTROT® NC PTCA Balloon Catheter ("FOXTROT® NC"), in-house developed by Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®"), recently 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). In previous years, FOXTROT® NC had gained the CE mark, and received approvals from Japan's Ministry of Health Labour and Welfare ("MHLW"), US Food and Drug Administration ("FDA") and China Food and Drug Administration ("CFDA"), and it was launched in the Philippines, Thailand and Brazil.
FOXTROT® NC is a non-compliant rapid exchange PTCA balloon dilatation catheter. The device features high burst pressure, low compliance and small balloon profile, which lead to its excellent pushability, trackability and crossability. FOXTROT® NC is indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery, for the purpose of facilitating the implantation of balloon expandable stents, preventing the edge effects, protecting healthy tissues, as well as improving myocardial perfusion.
Aside from FOXTROT® NC, MicroPort®'s FOXTROT® PRO Balloon Dilatation Catheter and Firehawk® Rapamycin Target Eluting Coronary Stent System also obtained approval from the COFEPRIS. Dr. Linda Lin, First Vice President of MicroPort® International Business, said: "By offering stent and balloon products used in the percutaneous coronary intervention ("PCI") in the Mexico market, MicroPort® is on the way to provide more comprehensive medical solutions for South American patients."