NEW YORK, Oct. 3, 2019 /PRNewswire/ — Centinel Spine, LLC, the largest privately-held spine company focused on anterior column reconstruction, today celebrated the 18th year of clinical usage of the prodisc® L Lumbar Total Disc Replacement in the United States.
prodisc L was first implanted in the United States during concurrent IDE studies to obtain FDA approval for one- and two-level use. The first implantation took place on this date 18 years ago at the Texas Back Institute by Jack Zigler, MD, as a part of the one-level study. The study provided the clinical data needed to support the eventual FDA approval for prodisc L in 2006. Results from the study have been published in numerous papers, which are part of the 540+ published studies on the prodisc technology platform.
Few medical devices remain as effective for such a long period of time. The usage of prodisc L continues to expand, growing nearly 40% over the last year due to expanded insurance carrier approvals. Several insurance carriers, including UnitedHealthcare and TRICARE, have recently changed their coverage decisions to enable reimbursement for lumbar disc replacements using prodisc L. These two insurers alone cover over 25 million patients in the United States.
The prodisc family of devices includes prodisc L, the most frequently implanted lumbar total disc replacement in the United States, as well as prodisc C Vivo, the most frequently implanted cervical total disc replacement in the world. Unparalleled clinical evidence underpinned by over 540 published studies substantiates the clinical safety and efficacy of these devices, and has led to substantial growth and expansion of use worldwide.
Centinel Spine recently celebrated thirty years of the use of prodisc technology outside the United States. The family of devices now consists of six devices, including an anterior and anterior-lateral approach lumbar disc replacement, and four cervical discs with a variety of endplate configurations designed to enable surgeons to better suit patient anatomy. All have a consistent mechanism of action and updated instrumentation to provide streamlined implantation. New developments to the family of products include the recently initiated clinical trial comparing the prodisc C Vivo and prodisc C SK™ devices with an approved cervical TDR product as a control, in order to validate their safety and effectiveness in an FDA IDE study.
“prodisc L has stood the test of time” stated Jack Zigler, MD, of the Texas Health Center for Diagnostics and Surgery, Texas Back Institute, Plano, TX. He continued “in my hands, for the right patient, prodisc L is an excellent device – with a very low re-operation rate, and a decreased impact on adjacent levels compared to circumferential fusion. I see many patients more than ten years after their prodisc L surgery who thank me for giving them their lives back.”
“prodisc‘s longevity substantiates its design principles; to provide a stable bone interface coupled with a mechanism of action enabling guided motion” stated Centinel Spine Chairman & CEO, John Viscogliosi. “Kudos to Dr. Zigler for recognizing the advantages of this technology 18 years ago, and my thanks for his continued support in educating about prodisc technology in the years since his landmark first implantation” Viscogliosi continued.
Centinel Spine will celebrate thirty years of the prodisc technology and highlight Company’s latest anterior column reconstruction technologies at the EUROSPINE Annual Meeting in Helsinki, Finland, held October 16-18, 2019 at Messukeskus Helsinki, the Expo and Convention Centre.
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.
The company recently 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.
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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