FDA Clears Life Spine’s PROLIFT Lateral HELO Fixation System

Life Spine has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its PROLIFT Lateral HELO Fixation System.

“The PROLIFT Lateral HELO Fixation System marries together our expandable technology with an integrated fixation plate. The system was designed to reduce procedural time, while providing a solution for cases that require sagittal balance and lordosis correction. Because of HELO’s unique design and our full lateral portfolio, we’re helping physicians migrate procedures into an ASC, potentially allowing patients a shorter procedure and a faster recovery,” said Mariusz Knap, senior vice president of Sales and Marketing for Life Spine.
 
Life Spine is the leader in Micro Invasive expandable solutions with more than 12 expandable 510(k) clearances and an additional 16 in the queue. Building upon the success of Life Spine’s Micro Invasive portfolio, PROLIFT Lateral HELO offers a patient-matched solution that is designed to save time, save money, and accelerate patient recovery.
 
PROLIFT Lateral HELO is an expandable lateral spacer with an integrated plating system allowing for restoration of disc height while providing additional lateral stabilization. The system is intended for a LLIF (Lateral Lumbar Interbody Fusion) and the ATP (anterior-to-psoas) approach. Utilizing the ATP approach avoids the psoas muscle, potentially eliminating nerve complications associated with the direct lateral technique. PROLIFT Lateral HELO is ideal for cases requiring maximum segmental lordosis given HELO’s unique expansion capabilities which allows for in situ lordotic adjustment anywhere from 5 degrees up to 20 degrees with a corresponding height range of up to 8mm of disc height restoration.