FDA Clears CoAlign’s AccuLIF® Expandable Interbody Device Product Line for Lateral Surgical Approaches

CoAlign Innovations, Inc.  has announced that its AccuLIF® XL lateral expandable interbody fusion devices have received marketing clearance from the U.S. FDA. This new product line addresses fusion procedures employing the lateral approach.

Background

Californian company CoAlign Innovations has developed a family of expandable interbody devices that it says are safe, simple and easy to use. The company’s novel 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.

This new AccuLIF XL lateral interbody device product line joins the AccuLIF TL (for TLIF) and AccuLIF PL (for PLIF) implants family and according to the company represents the broadest and most versatile line of expandable interbody devices available to spine surgeons.

Physician comments

Daniel Oberer, MD of Carolina Neurosurgery and Spine Associates in Charlotte, North Carolina, one the busiest spine surgery practices in the world, has used AccuLIF in numerous procedures. Dr. Oberer said, “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. 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.”

Company comments 

Paul Goeld, Executive Chairman of CoAlign added, “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. 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.”

Source: CoAlign Innovations, Inc., Business Wire