突发,强生Varipulse暂停美国销售

CHC医疗传媒
10 Jan

文章来源:器械之家1月8日,据路透社最新消息,强生医疗科技公司宣布由于在外部评估期间报告了4例神经血管事件,出于谨慎考虑,将暂停在美国使用其新上市的Varipulse脉冲场消融系统,并着手调查这些神经血管事件的根本原因。Varipulse脉冲电场消融系统于2024年11月获得美国食品和药物管理局(FDA)的批准,用于治疗药物难治性、症状性阵发性房颤患者。该系统在关键性“admIRE”试验中取得了...

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