非临床测试表明，在下列条件下，本支架可安全地进行核磁共振检查（MRI）：...

非临床测试表明，在下列条件下，本支架可安全地进行核磁共振检查（MRI）：...

冠心病亦称为缺血性心脏病，是我国危害最严重的疾病之一。冠心病的主要治疗方式是血运重建，常用的手术是经皮冠状动脉介入治疗（percutaneous coronary intervention，PCI）。采 用 药 物 洗 脱 支 架（drug-eluting stent，DES）是目前我国 PCI 的主要方式，它通过在金属支架表面包被携带药物（雷帕霉素或紫杉醇）的聚合物，使药物能逐步洗脱释放至血管壁组织，抑制血管平滑肌细胞及新生内膜过度增殖，从而显著改善冠状动脉再狭窄率。...

We aimed to investigate the feasibility, initial safety and efficacy of coronary intervention using FIREHAWK^®, a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES), in patients with complex anatomical and clinical scenarios....

Trials on the FIREHAWK stent allowing targeted sirolimus release were not individually powered to reliably estimate low-frequency safety endpoints such as stent thrombosis (ST) or to examine long-term safety and efficacy. Additionally, the China Food and Drug Adminis tration requires an objective performance criterion (OPC) study for new drug-eluting stents. ...