New Publication Supports Clinical Effectiveness of Centinel Spine's STALIF® Integrated Interbody™ System

WEST CHESTER, Pa., Oct. 26, 2021 /PRNewswire/ -- Centinel Spine^®, LLC, a leading global medical device company addressing cervical and lumbar spinal disease through anterior surgical access, today announced the recent publication of a research study on its STALIF C-Ti® product in the Journal of Surgery & Anesthesia Research: "Preliminary 12-Month Safety and Efficacy Outcomes for the Treatment of Cervical Radiculopathy and Myelopathy with the Stalif-C Integrated Interbody Fusion Device."¹ The prospective multi-center study supports that patients receiving STALIF C-Ti implants demonstrated significant improvements in clinical outcome scores with minimal overall complication rate.

The clinical study utilizing the STALIF C-Ti integrated cage-screw implants was performed in 145 patients and 12-month outcome scores demonstrated significant improvement in all available patient reported outcome scores collected (p<0.05 for all), including NDI, VAS neck, VAS left arm, and VAS right arm.

Co-investigator on the study Jad G. Khalil, MD of Michigan Orthopaedic Surgeons commented, "This is what I believe to be a very important multi-center study on stand-alone devices. There is very little data on stand-alone devices. And, while reference is frequently made comparing cervical fusions, the majority of those references are comparing plated fusions. This study was undertaken to determine if there was an advantage to an Integrated Interbody device over traditional plated fusion. The study was conducted at eleven centers across the country—a mix of private practice and university-based programs, with all data collected and entered into a validated database." Dr. Khalil concluded, "I believe this study will be very important in influencing fusion device selection and is long overdue."

Centinel Spine's CEO, Steve Murray, stated, "We are committed to providing clinical evidence to support our portfolio of devices and this study is one of the few multi-center prospective clinical evaluations of this type of technology. We are dedicated to advancing evidence that further supports the stand-alone fusion platform that was pioneered by Centinel Spine."

The STALIF C-Ti implant technology has been engineered based on the STALIF design, which has a history of over 30 years of clinical usage and has helped thousands of patients regain their lives. STALIF implants provide compressive fixation at the fusion site, pulling the vertebral bodies onto the implant and graft material to enhance opportunities for fusion in line with Wolff's Law of Bone Healing.

¹ Barrett Boody, Jad Khalil, Betsy Grunch, Michael Musacchio, Amir Vokshoor, et al (2021) Preliminary 12-Month Safety and Efficacy Outcomes for the Treatment of Cervical Radiculopathy and Myelopathy with the Stalif-C Integrated Interbody Fusion Device. Journal of Surgery & Anesthesia Research. SRC/JSAR-133. DOI: https://doi.org/10.47363/JSAR/2021(2)128.

About Centinel Spine, LLC

Centinel Spine^®, LLC is a leading global medical device company addressing cervical and lumbar spinal disease through anterior surgical access. The company offers a continuum of trusted, brand-name, motion-preserving and fusion solutions backed by over 30 years of clinical success—providing the most robust and clinically-proven technology platforms in the world for total disc replacement (prodisc®) and Integrated Interbody^™ fusion (STALIF®).

Centinel Spine continues to advance its pioneering culture and corporate mission to become a catalyst of change in the spine industry and alter the way spine surgery is perceived. Centinel Spine remains the only company with comprehensive motion-preserving and fusion solutions for both cervical and lumbar anterior column reconstruction.

For more information, please visit the company's website at www.CentinelSpine.com or contact:

Varun Gandhi
Chief Financial Officer
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Email: [email protected]

SOURCE Centinel Spine, LLC