Interventional Spine has obtained approval from the US Food and Drug Administration (FDA) for its next generation Opticage expandable interbody fusion device.
The new system is an enhanced version of the original Opticage system, which was launched in 2012.
The next generation Opticage system includes all of the beneficial features of the first-generation Opticage, providing continuous adjustable and reversible height, and better graft contact and containment.
It also features an improved ability to provide graft material through the implant after expansion compared against the previous implant.
Interventional Spine CEO Walter Cuevas said: "This represents another milestone for Interventional Spine as we continue to bring innovative surgical solutions to the spine market to address the needs of patients and surgeons worldwide.
"We are very excited about our next generation Opticage, as we believe this represents our pathway forward in creating a lumbar fusion platform that will be quickly accepted in the spine market."
According to the firm, it has multiple issued and pending patents on the Opticage design and methods of use.
The firm intends to offer several common sizes with the new advanced design device in sterile packages, allowing to address all of the commonly used surgical approaches to spinal fusion.
The company will start the marketing of the new Opticage from January next year.
Interventional Spine develops and markets patented implantable devices for the spine that can be deployed through percutaneous and MIS techniques.