FDA Awards Interventional Spine Clearance for Next-Gen Interbody Fusion Device
Irvine, Calif.-based Interventional Spine has won FDA clearance for its next generation Opticage expandable interbody fusion device.
The device — an enhanced version of the original Opticage system that was introduced in 2012 — features an improved ability to deliver graft material through the implant after expansion. It also has a streamlined profile and improved ergonomics, the company says.
The company plans to provide several common sizes in sterile packages to address all of the commonly used surgical approaches to spinal fusion.
Interventional Spine expects to begin shipping the device in January 2016. — Michael Cipriano