Healthcare Industry News:  Interbody fusion device 

Devices Neurosurgery Orthopaedic FDA

 News Release - August 19, 2013

CoAlign Innovations, Inc. Announces FDA Clearance of AccuLIF(R) Expandable Interbody Device Product Line for Lateral Surgical Approaches

REDWOOD CITY, Calif.--(Healthcare Sales & Marketing Network)--CoAlign Innovations, Inc. ( announced today that its AccuLIF® XL lateral expandable Interbody fusion devices have received marketing clearance from the United States Food and Drug Administration. This new product line addresses fusion procedures employing the lateral approach. This new AccuLIF XL lateral interbody device product line joins the AccuLIF TL (for TLIF) and AccuLIF PL (for PLIF) implants family and now represents the broadest and most versatile line of expandable interbody devices available to spine surgeons.

CoAlign Innovations has developed a family of expandable interbody devices that 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.

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."

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."

CoAlign Innovations is a privately held company based in Redwood City, California focused on improving outcomes for spine surgery patients through clinically significant innovation that is simple, easy to use and cost-effective.

* Data on file at CoAlign Innovations, Inc.

Source: CoAlign Innovations

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