Interventional Spine announced FDA clearance of its Lateral Opticage Expandable Intervertebral Body Fusion Device.
This device joins the Interventional Spine family of Opticage Expandable Interbody Fusion Devices previously cleared for TLIF earlier this year, and used with the Company’s PerX360 System.
The Opticage Expandable Intervertebral Body Fusion Device is a lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The Opticage Expandable Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach.
Mr. Walter A. Cuevas, Chief Executive Officer of Interventional Spine said: "With this milestone, Interventional Spine continues to lead the spine market in providing the most innovative solutions for surgeons, which in the end, benefit patients. This new indication for the Opticage Expandable Interbody Fusion Devices broadens the application of Interventional Spine’s technology to significantly more patients."
Interventional Spine is a privately held company based in Irvine, California, that designs, develops and markets patented minimally invasive implantable devices for the spine that can be deployed via percutaneous techniques. Supported by the Company’s unique product introduction systems, Interventional Spine’s products provide benefits to patients, surgeons and hospitals alike.