CoAlign Innovations, a US-based medical device company, has received the US Food and Drug Administration (FDA) approval for its AccuLIF XL lateral expandable interbody fusion devices.
The new AccuLIF interbody system utilizes low-profile delivery and placement with controlled expansion to provide precise anatomical reconstruction of the spine during fusion surgery.
The AccuLIF XL product line employs lateral approach in fusion procedures.
As expansion occurs, a proprietary system of small titanium steps within the implant deploys to create a rigid, monolithic structure.
During placement the AccuLIF system is inserted in its smallest form to minimize risk to nerve roots and damage to vertebral body endplates.
AccuLIF is also 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.
CoAlign executive chairman Paul Goeld noted because the lateral approach represents such a large and growing portion of the spine market, the company is very excited to add the XL device to the AccuLIF family.
"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," Goeld added.
By adding XL device to the AccuLIF product line, the company has expanded its family of expandable interbody devices that are safe, simple and easy to use.
CoAlign also plans to announce other additions to the AccuLIF family during the coming months.