More Opticage Sizes Cleared by FDA

Interventional Spine, Inc. now has FDA clearance for 11 additional sizes of its Opticage Expandable Interbody Fusion Device.

The company announcement, on February 12, 2014, stated that the new sizes allow surgeons to match an Opticage to more than 80% of their patients requiring lumbar fusion surgery. The device features a continuously adjustable height within a working range of 9mm to 14mm.

According to company CEO Walter Cuevas, this milestone will increase the market penetration of the device. “In fact, ” added Cuevas, “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.”

The device was introduced in mid-2012 and has been implanted in almost 1, 000 patients in the U.S., Spain, the United Kingdom, Italy, Brazil, Mexico and Chile.

Interventional Spine, founded in 2000, is a privately held company based in Irvine, California, that designs, develops and markets patented implantable devices for the spine that can be deployed via percutaneous and MIS techniques.

The basis of the company’s existing products is the Compression Locking Anchor with Secondary Purchase (CLASP) technology, originally designed for the podiatric and orthopedic trauma markets, and now implanted in over 4, 000 patients. The technology, according to the company, provides effective fixation in both normal and osteoporotic bone and enables surgeons to change the way they managed bone fractures, allowing for precise positioning with compression independent of thread movement, while providing superior pullout resistance and compression when compared to traditional lag screws.