Shanghai, China – 28 January 2014. Firehawk® Rapamycin Target Eluting Coronary Stent ("Firehawk®") has been approved for market launch by the China Food and Drug Administration ("CFDA"). Shanghai MicroPort Medical (Group) Co., Ltd ("MicroPort") in-house developed, Firehawk® drug-eluting stent ("DES"), is the company's third generation coronary stent used for the treatment of coronary artery stenosis and occlusion.
Mr. Zhirong Tang, the Vice President of Coronary R&D for MicroPort, stated, the applied targeted eluting technology allows Firehawk® to achieve the same clinical efficacy as other traditional DES with only 1/3 dosage of the drug, and therefore greatly improving the safety of Firehawk® DES while maintaining its excellent efficacy. Mr. Qiyi Luo, CTO of MicroPort stated: "Targeted Drug Eluting technology is the key milestone of DES technology's research and development. We have spent almost eight years on research and development to make Firehawk® the lowest drug dosage DES in the world. Firehawk® combines all the advantages of DES and bare metal stents. For MicroPort it represents a major leap forward, transforming our DES offering from a market follower to leader in this segment." Mr. Yimin Xu, Senior Vice President of Regulatory and Clinical Affairs of MicroPort said: "the introduction of Firehawk® is based on solid evidence-based medical data. MicroPort is the first company to conduct a large scale pre-market clinical study in accordance with <Guidance for Industry: Coronary Drug-Eluting Stents Clinical Studies>."
Firehawk® pre-marketing clinical studies consisted of three phases and 1,261 patients in total enrolled in clinical trials. This represents the largest scale premarket clinical trial of a coronary DES in China. Twenty-nine clinical centers in fourteen provinces throughout China witnessed the safety and effectiveness of Firehawk® in Target I randomized key trial, for the first time in China, Xience V (most popular DES in the United States of America and European market) was chosen for comparison with Firehawk®. The results of nine-month Angiographic follow-up, and one year clinical follow up show that Firehawk® has the same efficacy and safety as Xience V.
Dr. Runlin Gao, MD, (principal investigator for Firehawk® Target I Randomized Controlled Trial (RCT)) said, " The approval of Firehawk by CFDA, added a new therapy choice for the patients, the safety and efficacy of Firehawk were proved to be world class by the well conducted clinical trials. " and Dr. Martin B. Leon, MD, chairman of TCT, and the co-principal investigator of TARGET, had made comments during TCT 2012, "I think a device like this, with abluminal coating, biodegradable polymers staying in the grooves, not exposed and with a low drug dose, DAPT shorten to 3 months in the future should be reasonable, MicroPort should be considered as a world leader in DES with its Firehawk technology."
In the Chinese market Firebird stents have held the leading position for nine consecutive years and we believe the launch of Firehawk® will strengthen our leading position in the field of coronary intervention. MicroPort is committed to bringing Firehawk® to the international markets and the application for CE approval is in the process.