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Centinel Spine Announces FDA Approval for Two-level prodisc L Total Disc Replacement
April 16, 2020
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.
See Full Press Release: Centinel Spine Announces FDA Approval for Two-level prodisc® L Total Disc Replacement
Written by: Centinel Spine
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