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FDA限制Stryker Wingspan颅内支架系统的使用

2012-08-14 陈蓉 医学论坛网

       2012年8月8日,美国食品与药物管理局(FDA)批准Stryker Wingspan颅内支架系统包括适应证在内的标签修改,增加了新的禁忌症、使用警告及对该装置风险的详细描述。     颅内狭窄动脉或阻塞可减少颅内动脉血供,极大增加患者致死性卒中发生风险。对于颅内动脉严重狭窄目前有几种治疗方案可供选择,Wingspan支架系统可用

       2012年8月8日,美国食品与药物管理局(FDA)批准Stryker Wingspan颅内支架系统包括适应证在内的标签修改,增加了新的禁忌症、使用警告及对该装置风险的详细描述。
 
  颅内狭窄动脉或阻塞可减少颅内动脉血供,极大增加患者致死性卒中发生风险。对于颅内动脉严重狭窄目前有几种治疗方案可供选择,Wingspan支架系统可用于扩张颅内狭窄动脉而预防新发卒中。

  自2005年该系统被批准以来,包括SAMMPRIS(颅内动脉狭窄患者采取支架置入与积极药物治疗预防卒中复发研究)在内的临床试验数据表明,与单纯药物治疗相比,颅内支架置入可能增加部分患者的卒中和死亡风险。然而,入组SAMMPRIS研究的患者与其他试验入组患者有很大差异,这些差异影响了患者的获益和风险。

  经过对这些临床试验数据的回顾,FDA认为Wingspan支架系统依旧可以用于有限的患者,尤其是接受药物治疗存在卒中再发,在接受支架置入前7天无新发卒中症状的患者。Stryker将增强对临床医生使用Wingspan支架系统的培训,此外,FDA还要求Stryker提供更多的上市后监督研究数据。

相关链接:FDA revises safety information and limits use of Stryker Wingspan brain stent system,FDA,Aug. 8, 2012
 

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    2013-05-07 gostraight
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    2012-08-16 heli0118
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