NuVasive has received approval for instruments used in the Extreme Lateral Interbody Fusion (XLIF) procedure by the Japanese Ministry of Health, Labour and Welfare (MHLW).
Recent guidance from the MHLW requires dilators and associated components used in lateral access spine surgical procedures to be classified in Japan as Class III medical devices. NuVasive’s dilator, which is used in XLIF procedures, was originally approved in Japan as a Class II device in August 2011 with additional sizes approved in January 2014. NuVasive submitted its dilator and associated components for reclassification as Class III medical devices. Surgeons temporarily stopped performing XLIF procedures in Japan while the reclassification was pending.
With this approval from the MHLW, XLIF procedures in Japan will resume in the first quarter of 2017. In connection with the MHLW approval, NuVasive has agreed to provide additional training for surgeons with limited experience in XLIF and ensure that procedures are conducted at approved hospitals.
“We have worked diligently with the MHLW in obtaining the reclassified clearance for our dilators in Japan,” says Jason Hannon, NuVasive’s president and chief operating officer. “Over 150,000 patients have been treated with XLIF around the world, of which 5,000 operations have taken place in Japan since 2013.”