17 Apr Centinel Spine Announces FDA Approval for Two-level prodisc® L Total Disc Replacement
– prodisc L is the only total disc replacement system in the U.S. approved for two-level use in the lumbar spine.
– prodisc L has been clinically utilized across the world for over 20 years, with the first successful implantation in the U.S. in 2002.
– Centinel Spine is the only company with FDA approved cervical and lumbar total disc replacement devices.
NEW YORK, April 14, 2020 /PRNewswire/ — Centinel Spine®, LLC, the largest privately-held spine company focused on anterior column reconstruction, today announced FDA approval of two-level indications for the prodisc® L Lumbar Total Disc Replacement (TDR) system. Centinel Spine now becomes the only company in the world with an FDA-approved lumbar TDR device that has been clinically reviewed and found safe and effective for two-level use.
The prodisc L device was first implanted in the United States during concurrent IDE studies to obtain FDA approval for one and two-level use. The first two-level implantation in the U.S. took place on January 22, 2002 by Jack Zigler, MD at the Texas Health Center for Diagnostics and Surgery, Texas Back Institute, Plano, TX as a part of the two-level study. Results from the study have been published in numerous papers and are part of the over 540 published studies on the prodisc technology platform.
“Patients with two-level prodisc L disc replacements have done remarkably well in long-term follow-up,” Dr. Zigler noted. He continued, “We began two-level prodisc L implantations in January 2002 at the Texas Back Institute as an enrolling site in the FDA study. I have now seen multiple two-level disc replacement patients with over 15-year follow-up who are still delighted with their clinical results—and have not needed additional surgery that is commonly required after initial fusion surgery. Patients with two-level disc replacement are among my most grateful patients.”
“The prodisc technology’s remarkable safety and efficacy profile is a tribute to the design of the device,” stated Centinel Spine CEO Steve Murray. “The longevity of the prodisc technology is due to the design principles of a stable bone interface, a consistent mechanism of action enabling guided motion, and instrumentation that facilitates efficient and reliable implantation,” Murray concluded.
The prodisc family of devices now consists of six devices, including an anterior and anterior-lateral approach lumbar disc replacement and four cervical disc replacement implants with a variety of endplate configurations designed to enable surgeons to better suit patient anatomy. New developments to the family of products include a recently initiated clinical trial comparing the prodisc C Vivo and prodisc C SK devices with an approved TDR product as a control, in order to validate their safety and effectiveness in an FDA IDE study.
About Centinel Spine, LLC
Centinel Spine®, LLC is the largest privately-held spine company focused on anterior column reconstruction. 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 Total Disc Replacement and Integrated Interbody™ portfolios in the world.
The company began operations in 2008 through the merger-acquisition of two pioneering medical device companies—Raymedica, LLC and Surgicraft, LTD. In 1988, UK-based Surgicraft launched the first Stand-Alone/No Profile® anterior lumbar interbody fusion device in the world, which was the basis for future generations of the market-leading Integrated Interbody technology platform known today as STALIF®. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission to become the worldwide leading company addressing spinal disease anteriorly with the widest breadth and depth of technology platforms.
In December, 2017, the company acquired the prodisc® Total Disc Replacement Technology Platform—the most extensive cervical and lumbar motion-preserving reconstruction portfolio available today. With the addition of prodisc, Centinel Spine stands alone as the only company with comprehensive motion-preserving and fusion solutions for both cervical and lumbar anterior column reconstruction.
In June, 2019, the company entered into partnership with professional athlete Tiger Woods. Woods underwent spinal fusion surgery using Centinel Spine’s STALIF M-Ti™ Anterior Lumbar Integrated Interbody fusion product in April 2017 to alleviate ongoing, debilitating pain in his back and legs.
Centinel Spine derived its name from the “Sentinel Sign”, the radiographic confirmation of a successful fusion anterior to the interbody device.
For more information, please visit the company’s website at www.CentinelSpine.com or contact:
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