NuVasive received Japan regulatory approval for instruments used in the eXtreme Lateral Interbody Fusion (XLIF®) procedure by the Japanese Ministry of Health, Labour and Welfare (MHLW). The procedures will resume in 1Q17.
Due to recent guidance from Japan’s MHLW, dilators and associated components used in lateral access spine procedures were to be classified as Class III medical devices. NuVasive’s dilator was originally approved as a Class II device in 3Q11, with additional sizes approved in 1Q14. NUVA submitted components for reclassification, and surgeons had temporarily stopped performing XLIF procedures in Japan pending reclassification.
To date, >150,000 patients have been treated with XLIF globally, with 5,000 procedures occurring in Japan since 2013.
NuVasive received Japan regulatory approval for instruments used in the eXtreme Lateral Interbody Fusion (XLIF®) procedure by the Japanese Ministry of Health, Labour and Welfare (MHLW). The procedures will resume in 1Q17.
Due to recent guidance from Japan's MHLW, dilators and associated components used in lateral access spine procedures were...
NuVasive received Japan regulatory approval for instruments used in the eXtreme Lateral Interbody Fusion (XLIF®) procedure by the Japanese Ministry of Health, Labour and Welfare (MHLW). The procedures will resume in 1Q17.
Due to recent guidance from Japan’s MHLW, dilators and associated components used in lateral access spine procedures were to be classified as Class III medical devices. NuVasive’s dilator was originally approved as a Class II device in 3Q11, with additional sizes approved in 1Q14. NUVA submitted components for reclassification, and surgeons had temporarily stopped performing XLIF procedures in Japan pending reclassification.
To date, >150,000 patients have been treated with XLIF globally, with 5,000 procedures occurring in Japan since 2013.
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