New Delhi, India –On July 14, Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®"), in-house developed by Shanghai MicroPort Medical (Group) Co ("MicroPort®"), was granted market approval by India's Central Drugs Standard Control Organization, the national regulatory body for Indian pharmaceuticals and medical devices.
The revolutionary third-generation drug-eluting stent Firehawk® is the result of eight years of research and development of MicroPort® and is the world's first and only target eluting stent ("TES"). As the world`s lowest drug dosage stent, Firehawk® combines the merits of bare metal stents and drug-eluting stents ("DES"). It adopts unique laser outer-surface-groove drug-coating technology and target-eluting technique, which allow Firehawk® to achieve the same clinical efficacy with largely lowered drug loadings, beneficial for vascular early healing.
There are about 30 million patients suffering from heart diseases in India, and cardiovascular disease is the leading health killer in this second most populous country of the world. As Firehawk® is permitted for market launch in India, it will provide a more ideal solution for local patients with cardiovascular disease.
Firehawk® received the registration certificate from China Food and Drug Administration and the CE Mark approval from the European Notified Body, and was approved for market launch in 17 overseas countries including Brazil in South America, and Thailand, the Philippines and Indonesia in Asia. Firehawk®'s market launch in India, one of the largest markets in Asia, will accelerate the development of MicroPort®'s international business, and will increase the impact of MicroPort® brand and products on India's surrounding countries.
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