Here are five quick notes:
1. The MHLW classified the technology as a Class III medical device. The XLIF procedure was originally approved in August 2011 as a Class II device and additional dilator sizes were approved in January 2014.
2. The company submitted the dilator and associated components for reclassification as a Class III medical device and since that time surgeons temporarily stopped performing the XLIF procedure in Japan.
3. The surgeons will resume performing XLIF in the first quarter of 2017. In connection with the MHLW approval, NuVasive will provide additional surgeons with experience performing the XLIF procedures and the surgeries will be performed at approved hospitals.
4. XLIF is a minimally invasive surgical procedure where surgeons use proprietary neuromonitoring and an integrated portfolio of instruments and implants to correct a range of spinal pathologies.
5. There are more than 350 peer-reviewed journal articles around the world examining XLIF and outcomes 11 years after surgery. Surgeons have performed XLIF on more than 150,000 patients around the world and 5,000 operations in Japan since 2013.
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