The approval is the final hurdle to launching NuVasive’s Integrated Global Alignment platform in Japan, the company said.
“Japan’s exceptional growth over the last 3 years demonstrates the clear benefit of focusing our market penetration efforts around our complete procedural offerings such as XLIF, which we are now replicating in additional key international markets,” international executive vice president Jason Hannon said in prepared remarks.
“With the pending launch of iGA in Japan, we expect to drive robust adoption of this technology to address proper spinal alignment and drive improved long-term patient outcomes. In doing so, we aim to mirror the positive impact iGA has already had in driving our strong lumbar momentum in the U.S. over the past several quarters. The continued success of our Precept posterior fixation system, augmented now by the approval of Reline, supports our confidence in fueling more than 30% growth in our Japanese market for the year as we look to approach the $40 million revenue mark for 2016 – a key contributor to our core NuVasive international growth of approximately 20% this year,” Hannon said.
NuVasive said the Reline system is designed for preserving or restoring spinal alignment in treating deformity and degenerative conditions.
Earlier this week San Diego-based NuVasive said it plans to acquire its Brazilian distributor, Mega Surgical, for an undisclosed amount.