NuVasive Inc. (NSDQ:NUVA) said today that it won approval from the Japanese Ministry of Health, Labor & Welfare for the return of instruments used in its eXtreme lateral interbody fusion procedure to the market in Japan.
San Diego-based NuVasive said instruments and components used in lateral access procedures are Class III devices in Japan, despite the fact that it’s XLIF dilator was originally approved in 2011 as a Class II device (additional sizes were approved in Japan in 2014, the company said). Surgeons there, who halted XLIF procedures while NuVasive sought a reclassification, will be able to resume during the 1st quarter next year, NuVasive said.
NuVasive said it agreed to provide additional training for surgeons with limited experience in XLIF and ensure that procedures are conducted at approved hospitals.
“We’ve worked diligently with the MHLW in obtaining the reclassified clearance for our dilators in Japan,” president & CEOO Jason Hannon said in prepared remarks. “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 said it plans to issue its 2017 guidance next month at the annual J.P. Morgan Healthcare Conference in San Francisco.