RegulatorySpine

Life Spine Announces FDA 510(k) Clearance for the PROLIFT® Lateral HELO Fixation System

May 4, 2021

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a leading medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the PROLIFT Lateral HELO Fixation System.

Life Spine is the leader in Micro Invasive™ expandable solutions with over 12 expandable 510(k) clearances and an additional 16 in the queue. Building upon the well-established 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˚ 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.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Contacts

Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

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Chris J. Stewart

Chris currently serves as President and CEO of Surgio Health. Chris has close to 20 years of healthcare management experience, with an infinity to improve healthcare delivery through the development and implementation of innovative solutions that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help achieve better patient outcomes. Previously, Chris was assistant vice president and business unit leader for HPG/HCA. He has presented at numerous healthcare forums on topics that include disruptive innovation, physician engagement, shifting reimbursement models, cost per clinical episode and the future of supply chain delivery.

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