Bogota, Colombia – Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") recently obtained the regulatory approval from Colombia's health authority INVIMA for its in-house developed Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®"). It is Firehawk®'s first registration certificate in Latin America that was gained through self-registration, with the holder of the certificate being "Shanghai MicroPort Medical (Group) Co., Ltd." Previously, Firehawk® has received approval in several other Latin American countries, such as Brazil, Mexico and Argentina.
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. 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.
As the third largest country in Latin America, Colombia has a population of 50 million with a huge, growing market for cardiovascular interventional products. Dated back to May 2016 when Mr. Ricardo Galindo Bueno, Colombian Consult General in Shanghai, visited MicroPort® headquarters, he showed his expectation in seeing MicroPort® products launched in Colombia, and suggested that the company may take Colombia as a good platform to further open markets in Central and South America to serve more patients. Dr. Linda Lin, First Vice President of MicroPort® International Business, said:" As we obtained the certificate through self-registration this time, we can more effectively expand the Colombian market with less external uncertainties. In the future, MicroPort® will introduce more high-end medical devices to Colombia and other Latin American countries to benefit more patients."