CoAlign Adds to Spine Interbody Device Line

CoAlign Innovations Inc., a Redwood City, Calif.-based spine technology company, has gained 510(k) clearance from the U.S. Food and Drug Administration for its AccuLIF (lumbar interbody fusion) XL expandable interbody device product line for lateral surgical applications (pictured left). This new line of products joins the AccuLIF TL (for transforaminal LIF) and AccuLIF PL (for posterior LIF).

According to CoAlign, AccuLIF interbody system employs low-profile delivery and placement with controlled expansion to provide precise anatomical reconstruction of the spine during fusion surgery. As expansion occurs, a proprietary system of small titanium steps within the implant deploys to create a rigid, monolithic structure. Because it is inserted in its smallest form, the AccuLIF system is designed to minimize risk to nerve roots and damage to vertebral body endplates during placement.

“AccuLIF is simple to use and provides surgeons the ability to powerfully restore the lordosis and balance of the lumbar spine in a safe and effective manner,” said Daniel Oberer, M.D., of Carolina Neurosurgery and Spine Associates in Charlotte, N.C. “This work is often performed in tight spaces. Having the ability to ‘go in small’ and easily expand the device to the precise size required for that patient provides unparalleled control. AccuLIF is an exciting development for spine surgeons.”

“Because the lateral approach represents such a large and growing portion of the spine market, we are very excited to add the XL device to the AccuLIF family,” said Paul Goeld, executive chairman of CoAlign. “We will be announcing other additions to the AccuLIF family during the coming months. As innovators, we enjoy a close relationship with leading spine surgeons in the world and look forward to expanding our presence to major surgical programs across the country.”