Interventional Spine, a medical device company, has obtained the US Food and Drug Administration (FDA) approval for 11 additional sizes of the Opticage expandable interbody fusion device.
According to Interventional Spine, these new sizes will allow surgeons to match an expandable Opticage to more than 80% of their patients requiring lumbar fusion surgery.
Interventional Spine CEO Walter A Cuevas noted with this milestone, the company continues the practice of partnering with top surgeons around the world in providing the best solutions for patients.
"These new sizes expand the application of Interventional Spine’s technology to significantly more patients and increase the market penetration of the Opticage. In addition, due to its unique expansion properties, the Opticage Expandable Interbody Fusion Device provides an excellent alternative to surgeons performing lumbar interbody fusions, whether via percutaneous or MIS procedures.
"In fact, in combination with Interventional Spines’ PerX360 technology, the Opticage gives the surgeon the capability of performing a lumbar interbody fusion via a 12mm incision while protecting the surrounding nerves, which is unique in the world."
Interventional Spine’s Opticage expandable interbody fusion device has a continuously adjustable height within a working range of 9-14mm.
Since its launch in 2012, approximately 1,000 implants of the Opticage have been performed across the globe. It has benefitted patients in the US, Spain, the UK, Italy, Brazil, Mexico and Chile.