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, 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, and surgeons had 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've worked diligently with the MHLW in obtaining the reclassified clearance for our dilators in Japan," said 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. 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."
XLIF is a minimally invasive surgical (MIS) procedure performed through the side of the body, utilizing proprietary neuromonitoring and an integrated portfolio of instruments and specialized implants for treating a range of spinal pathologies. There are more than 350 peer-reviewed global journal articles reporting on the XLIF procedure over the last 11 years, which detail the positive outcomes and benefits of a lateral approach to the spine compared to traditional posterior and anterior approaches.
The company intends to provide preliminary guidance for 2017 revenue on Jan. 9.
NuVasive develops minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, the San Diego, Calif.-based company develops innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive's highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 2,200 person workforce in more than 40 countries around the world.