FDA clears Opticage body fusion device for treatment of degenerative disc disease


The US Food and Drug Administration has cleared the Opticage expandable intervertebral body fusion device (Interventional Spine) used in the treatment of degenerative disc disease. 

With the Optiport access instrument, which provides percutaneous access to the disc space, the Opticage expandable interbody forms an integral part of Interventional Spine’s PerX360 system. According to a company press release, this is the first and only system in the world capable of providing surgeons the ability to perform a complete percutaneous lumbar interbody fusion via two 15mm incisions for the treatment of lumbar discogenic pain.

David L Greenwald, Flagler Brain and Spine Institute, St Augustine, Florida, commented: “This is a significant milestone in the progression of making lumbar spinal fusion surgeries less invasive to patients. No other company has the cadre of technologies that allow surgeons to perform a full lumbar fusion via two 15mm incisions. To my knowledge, no other interbody fusion cage in the market has the expansion capabilities of the Opticage. Because of this characteristic, the channel for insertion is reduced and will help minimise tissue trauma and decrease the patient overall recovery times. This is the future of spinal surgery.”

“This approval provides Interventional Spine with a unique technology, capable of transforming how lumbar spine fusion is performed. In turn, our patients will experience less pain, shorter hospital stays and better outcomes overall,” said Cully White, Neurosurgery and Spine, Milwaukee, Wisconsin.