Centinel Spine receives FDA approval for two-level total disc replacement system
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Centinel Spine LLC received FDA clearance for its prodisc L lumbar total disc replacement system, the first device of its kind to be clinically tested and approved for two-level use, according to a company press release.
The device has done “remarkably well” in long-term follow-up, Jack Zigler, MD, who performed the study, said in the release.
“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,” Zigler said in the release.
“The prodisc technology's remarkable safety and efficacy profile is a tribute to the design of the device,” Steve Murray, CEO of Centinel Spine, said in the release. “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.”
Reference:
https://centinelspine.press/2020/04/13/centinel-spine-announces-fda-approval-for-two-level-prodisc-l-total-disc-replacement/
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https://centinelspine.press/2020/04/13/centinel-spine-announces-fda-approval-for-two-level-prodisc-l-total-disc-replacement/
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