The implants are NuVasive’s 1st inter-body fusion cages to be approved in Japan, according to the San Diego-based medical device company.
"This is an exciting stepping stone for NuVasive! For several years, we have been thoughtfully laying the groundwork and making the investments to support a direct operation in Japan, a market estimated to be close to $400 million in size," chairman & CEO Alex Lukianov said in prepared remarks. "We are proud to see all of those efforts coming to fruition so that our revenue ramp can begin in earnest at the start of the 1st quarter."
Lukianov said that NuVasive expects to introduce the company’s cervical and posterior thoraco-lumbar solutions, and lateral XLIF solution to Japanese market.
The CoRoent platform in March received FDA clearance. The devices are used for anterior cervical inter-body fusion and indicated for single-level reconstruction of degenerated cervical discs from the C2-C3 to C7-T1 vertebrae after discectomy, according to the company’s website.
NuVasive in October won FDA approval for its PCM cervical disc system, an implant designed to preserve motion in the cervical spine, in lieu of a standard fusion procedure.
Medtronic (NYSE:MDT) in August filed a lawsuit accusing NuVasive of patent infringement activity. NuVasive vowed to “vigorously” defend against Medtronic‘s claims in a long-running patent-infringement row over spinal devices.