Congratulations on MicroPort's G-2 DES Getting SFDA Approval
In January16, 2008, the second-generation DES (drug-eluting stent) independently developed by MicroPort Medical received the approval from State Food and Drug Administration (SFDA) after our first-generation DES was approved to be commercialized, which kicked off the development of China-made DES.
Compared with the G-1 DES Firebird with over 200,000 successful application cases, Firebird2 inherits Firebird's good transport performance and get improved in such aspects as higher stent strength and better biological compatibility of coating material. Clinical data submitted to SFDA showcase Firebird2's outstanding clinical manifestation: according to 6-month antigiographic follow-up, the late loss is merely 0.05mm, and the volumetric blockage rate of new inner membrane is only 1.26%. This result has been published in TCT2006.The two-year follow-up visit has been completed, during which no adverse event occurred to any of selected patients after stopping medication.
The Firebird2 development lasted 4 years and the process includes screening of coating material, animal test, biological safety inspection and clinical evaluation as well as technical evaluation by experts. The safety and validity of Firebird2 has withstood various stringent tests.
The success of Firebird2 will further sharpen MicroPort's market competitiveness in coronary intervention field. Firebird2 will meet the expectation of interventional specialists and surely make a big contribution to health cause.
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