Medical device firm NuVasive has secured approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for instruments used in the extreme lateral interbody fusion (XLIF) procedure.
XLIF is a minimally invasive surgical (MIS) procedure carried out through the side of the body by using neuromonitoring and an integrated portfolio of instruments and specialized implants to treat a range of spinal pathologies.
As per the MHLW guidance, the dilators and associated components used in lateral access spine surgical procedures required to be classified as class III medical devices in the country.
NuVasive's dilator, which is used in XLIF procedures, was first approved in Japan as a Class II device in August 2011. The device secured approval for additional sizes in January 2014.
The company submitted its dilator and associated components for reclassification as class III medical devices.
The latest approval allows the company to use its instruments in XLIF procedures in Japan, and is planning to resume procedures in the first quarter of this year.
NuVasive president and COO Jason Hannon said: “Over 150,000 patients have been treated with XLIF around the world, of which 5,000 operations have taken place in Japan since 2013.
“As the industry leader in lateral procedures, we take our leadership responsibility seriously and have worked diligently with the MHLW to make XLIF available in Japan again.
“We thank the MHLW and our surgeon partners in Japan for supporting our efforts in keeping industry-leading innovation available to patients in need."
NuVasive is engaged in the development and production of minimally invasive and procedurally-integrated spine solutions, including access instruments, implantable hardware and software systems for surgical planning.