MicroPort's Firehawk DES Approved in Europe

January 23, 2015—MicroPort Scientific Corporation announced that it has received European CE Mark approval for its Firehawk rapamycin target eluting coronary stent system. The Firehawk stent system will be available in broad size configurations, including diameters from 2.25 mm to 4 mm and lengths of 13 mm to 38 mm.

Firehawk is MicroPort’s third-generation drug-eluting stent (DES), following the Firebird rapamycin-eluting coronary stent and Firebird2 rapamycin-eluting coronary cobalt-chromium stent. MicroPort, which is based in Shanghai, China, first received China Food and Drug Administration for Firehawk in January 2014.

According to the company, the target drug-eluting technology combines the merits of bare-metal stents and DESs. The Firehawk stent features a 100% biodegradable polylactic acid polymer and sirolimus drug combination, which is intended to ensure a steady and constant drug-release rate, as well as MicroPort’s 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 DESs. 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 postprocedure dual-antiplatelet therapy, stated the company.

The company advised that later this year it expects to commence a European-based, large-scale, randomized clinical trial to further study Firehawk’s clinical performance.

According to the company, the Firehawk stent has been extensively studied in China in 1,261 patients through the TARGET clinical program. Through the TARGET I study, a prospective, randomized, noninferiority trial, the Firehawk stent was noninferior to Abbott Vascular’s Xience V stent for the primary endpoint of in-stent late lumen loss at 9-month follow-up (0.13 ± 24 mm vs 0.13 ± 18 mm; P = .94) and had a comparable clinical outcome at 3 years. In addition, the 3-year patient follow-up results showed that there were still no significant differences between the two groups up to 3 years, and no definite/probable stent thrombosis occurred in the Firehawk group.