FDA Grants Expanded Clearance for Interventional Spine’s Opticage Device

Irvine, Calif.-based Interventional Spine Inc. received U.S. Food and Drug Administration clearance for 11 additional sizes of its Opticage expandable interbody fusion device. According to the company, the new sizes will allow surgeons to match an expandable Opticage to more than 80 percent of their patients requiring lumbar fusion surgery.

The Opticage system features a continuously adjustable height within a working range of 9 to 14 millimeters. Since market release in mid-2012, there have been close to 1,000 implants of the Opticage worldwide, the company reported. So far, the device has been implanted in patients in the United States, Spain, the United Kingdom, Italy, Brazil, Mexico and Chile.

“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,” said Walter A. Cuevas, CEO. “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 (minimally invasive) 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 12 millimeter incision while protecting the surrounding nerves, which is unique in the world.”

Interventional Spine is a privately held company that designs implantable devices for the spine that can be deployed via percutaneous and MIS techniques.