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美敦力给药系统获FDA上市批准

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美敦力公司IN.PACT Admiral药物涂层球囊系统最近获得了FDA的上市批准。

  美敦力公司IN.PACT Admiral药物涂层球囊系统最近获得了FDA的上市批准。该仪器主要通过作用于股骨表层腘动脉治疗外周动脉阻塞类疾病。该仪器通过球囊充气将紫杉醇类抗细胞增殖药物施加至病人病灶,通过防止疤痕组织形成治疗动脉阻塞。该设备自2009年以来为全欧洲十万动脉阻塞患者带来了福音。从今天开始,它也将造福于全美乃至全球动脉阻塞患者。

  经过了长达一年的验证试验,IN.PACT Admiral已被确切证实了能够有效地保证动脉阻塞患者拥有一个开放的动脉腔。与传统的经皮腔内血管成形术相比,该技术手段疗效更为明显。该项技术能够有效地减少动脉阻塞患者的动脉壁疤痕组织再生,防止痊愈后的动脉阻塞患者再度受到动脉阻塞的困扰,在更长时间内维持动脉阻塞患者的身体健康。

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  Medtronic received FDA approval for its IN.PACT Admiral drug-coated balloon for treatment of peripheral artery disease in the superficial femoral and popliteal arteries of the upper leg. As the balloon is inflated it emits paclitaxel, an antiproliferative medication, to prevent scar tissue from forming around the treatment site and blocking the artery anew. The device has been cleared in Europe since 2009 and has already been used in approximately 100,000 patients.
  The IN.PACT Admiral has proven effective in maintaining patency of the arterial lumen after one year in a trial when compared with traditional percutaneous transluminal angioplasty. The reduced cases of restenosis will help prevent repeat procedures to re-open up the vessels and aid in maintaining a healthy lifestyle for those receiving the treatment.
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