Shanghai, China – 23 January, 2015 – MicroPort Scientific Corporation (HKEx: 853) ("MicroPort") announced today that it has received CE Mark approval from the European Notified Body for its Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®"). Firehawk® is MicroPort's third-generation drug eluting stent ("DES") following Firebird™ Rapamycin-Eluting Coronary Stent and Firebird2™ Rapamycin-Eluting Coronary CoCr Stent. First approved in China by the China Food and Drug Administration ("CFDA") in January 2014, Firehawk® is currently being widely used in China to treat patients with coronary artery disease. With the Firehawk® CE Mark approval, MicroPort is now able to offer Firehawk® to hospitals to treat patients with coronary artery disease in European countries that recognize the CE Mark. The Firehawk® stent system will be available in broad size configurations including diameters from 2.25 mm to 4.0 mm and lengths of 13 mm to 38 mm.
"Achieving the CE Mark approval for Firehawk® is just the latest achievement for MicroPort in becoming a global medical device company," said Dr. Zhaohua Chang, Founder, Chairman and Chief Executive Officer of MicroPort. "We look forward to bringing this truly innovative DES product to Europe in order to give European patients the best possible treatment alternatives for coronary artery disease."
The revolutionary target drug-eluting technology is the result of eight years of research and development to create what MicroPort believes to be the world's first and only target eluting stent ("TES"). The unique technology combines the merits of bare metal stents and DES. The Firehawk® Stent features a 100% biodegradable PLA polymer and sirolimus drug combination, which ensures a steady and constant drug release rate, and a proprietary, abluminal groove-filled design on the outer surface of the stent. These features allow the Firehawk® stent to have a targeted release of the rapamycin drug to the coronary vessel wall, thereby significantly reducing the total drug load delivered to the coronary artery of a patient receiving the Firehawk® stent as compared to other DES. This technology provides the same level of restenosis reduction as a conventional DES while offering faster and more complete vessel healing after stent implantation, which could potentially reduce the duration of post-procedure dual antiplatelet therapy.
"The Firehawk® stent is truly an innovative DES technology that has proven to be safe for patients and offers tremendous potential in improving the safety and clinical efficacy for patients with coronary artery disease," says Qiyi Luo, the Chief Technology Officer of MicroPort. "We look forward to building upon the existing body of clinical data for Firehawk® through a European based, large-scale, randomized clinical trial to further study Firehawk®'s clinical performance which we expect to commence later this year."
The Firehawk® stent has been extensively studied in China in 1,261 patients through a comprehensive clinical program called TARGET, which has set the new clinical trial design standard for the China DES market. Through the TARGET I study, a prospective, randomized, non-inferiority trial, the Firehawk® stent was non-inferior to Abbott's Xience V stent for the primary endpoint of in-stent late lumen loss ("ILL") at nine-month follow-up (0.13±24 mm vs. 0.13±18 mm, p=0.94) and had a comparable clinical outcome at three years. In addition, the three-year patient follow-up results showed that there were still no significant differences between the two groups up to three years, and no definite/probable stent thrombosis occurred in the Firehawk® group. These TARGET clinical program data have been presented in the last several years at the leading interventional cardiology conferences throughout the world including the China Interventional Therapeutics ("CIT") conference in China, the EuroPCR conference in Europe, and the Transcatheter Cardiovascular Therapeutics ("TCT") conference in the United States.