Interventional Spine announces FDA clearance of additional sizes of Opticage expandable interbody fusion device


Interventional Spine has announced the US Food and Drug Administration (FDA) clearance of eleven additional sizes of the Opticage expandable interbody fusion device. The new sizes will allow surgeons to match an expandable Opticage to more than 80% of their patients requiring lumbar fusion surgery. 

According to a press release, the Opticage expandable interbody fusion device features a continuously adjustable height within a working range of 9mm to 14mm. Since market release in mid-2012, there have been close to 1,000 implants of the Opticage worldwide, with exceptional clinical results. The device has benefitted patients in the United States, Spain, the United Kingdom, Italy, Brazil, Mexico and Chile.

Walter A Cuevas, chief executive officer of Interventional Spine says: “With this milestone, Interventional Spine 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.”