Centinel Spine has announced US Food and Drug (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 company said in a press release.
The prodisc L device was first implanted in the USA during concurrent IDE studies to obtain FDA approval for one and two-level use. The first two-level implantation in the US took place on January 22, 2002 by Jack Zigler at the Texas Health Center for Diagnostics and Surgery (Plano, USA) 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,” 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.