Life Spine Gains FDA 510(k) Clearance for PROLIFT Lateral HELO Fixation

By Julie A. Vetalice

Life Spine Gains FDA 510(k) Clearance for PROLIFT Lateral HELO Fixation

Life Spine received FDA 510(k) clearance to market the PROLIFT® Lateral HELO Fixation System. 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 integrated plating to support restoration of disc height while providing additional lateral stabilization. The system is intended for Lateral Lumbar Interbody Fusion and the anterior-to-psoas approach, which avoids the psoas muscle.

PROLIFT Lateral HELO is suitable for cases requiring maximum segmental lordosis given HELO’s unique expansion capabilities, which allow for in situ lordotic adjustment anywhere from 5˚ up to 20˚ with a corresponding height range of up to 8mm of disc height restoration.

“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 & Marketing for Life Spine.

Product Labels: Lumbar Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory