MicroPort has received CE mark approval from the European Notified Body for its Firehawk rapamycin target eluting coronary stent system.
Firehawk is MicroPort’s third-generation drug-eluting stent following Firebird rapamycin-eluting coronary stent and Firebird2 rapamycin-eluting coronary CoCr stent. First approved in China by the China Food and Drug Administration 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 recognise the CE mark. The Firehawk stent system will be available in several size configurations including diameters from 2.25mm to 4mm and lengths of 13mm to 38mm.
“We look forward to bringing this truly innovative product to Europe in order to give European patients the best possible treatment alternatives for coronary artery disease,” said Zhaohua Chang, founder, chairman and chief executive officer of MicroPort.
The 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. The unique technology combines the merits of bare metal stents and drug-eluting stents.
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 drug-eluting stents. This technology provides the same level of restenosis reduction as a conventional drug-eluting stents 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 has been studied in 1,261 patients in China through a comprehensive clinical program called TARGET, which has set the new clinical trial design standard for the Chinese drug-eluting stent market. Through the TARGET I study, a prospective, randomised, non-inferiority trial, the Firehawk stent was non-inferior to the Xience V stent (Abbott Vascular) for the primary endpoint of in-stent late lumen loss at nine-month follow-up (0.13±24mm vs. 0.13±18mm; 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 interventional cardiology conferences throughout the world including the China Interventional Therapeutics conference in China, the EuroPCR conference in Europe, and the Transcatheter Cardiovascular Therapeutics conference in the USA.