Interventional Spine, Inc. today announced the FDA clearance of their next generation Opticage® Expandable Interbody Fusion Device. The next generation system is an enhanced version of the original Opticage® system that was introduced in 2012.
This next generation Opticage® system continues to provide all of the beneficial features of the first-generation Opticage®, such as tactile feel, continuously adjustable and reversible height, and superior graft contact and containment compared to competitive expandable interbody cages. The next generation Opticage®, also features an improved ability to deliver graft material through the implant after expansion, has a streamlined profile compared to the previous implant, and has improved ergonomics. The Company has multiple issued and pending patents on the Opticage® design and methods of use.
Interventional Spine plans to provide several common sizes with the new advanced design device in sterile packages, with the intention of providing a full line offering of sizes and addressing all of the commonly used surgical approaches to spinal fusion. Since market release in mid-2012, there have been close to 2,000 implants worldwide of the original Opticage® with exceptional clinical results.
Mr. Walter A. Cuevas, Chief Executive Officer of Interventional Spine 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."
Interventional Spine expects to begin shipping this new Opticage® in January 2016.
Interventional Spine, Inc.