US-based privately-held spine company Centinel Spine has received the US Food and Drug Administration (FDA) approval for its two-level prodisc L Lumbar Total Disc Replacement (TDR) system.
With the approval, prodisc L is now claimed to be the only total disc replacement system in the US approved for two-level use in the lumbar spine.
Centinel Spine CEO Steve Murray said: “The prodisc technology’s remarkable safety and efficacy profile is a tribute to the design of the device.
“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”.
prodisc L device was first implanted in the US during IDE studies for FDA approval
With the latest approval, prodisc family of devices will comprise six devices, including an anterior and anterior-lateral approach lumbar disc replacement and four cervical disc replacement implants with different endplate configurations to better suit patient anatomy.
A recent clinical trial which compared the prodisc C Vivo and prodisc C SK devices with an approved TDR product as a control is the new development to the family of products. The trial is aimed at validating their safety and effectiveness in an FDA IDE study.
Centinel Spine said that its prodisc L device was first implanted in the US during concurrent IDE studies to obtain FDA approval for one and two-level use.
Jack Zigler from Texas Health Center for Diagnostics and Surgery has carried out the first two-level implantation in the US, as a part of the study.
Zigler said: “Patients with two-level prodisc L disc replacements have done remarkably well in long-term follow-up. 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.”
Centinel Spine commenced operations in 2008 through the merger-acquisition of medical device companies—Raymedica and Surgicraft.
In December, 2017, the company acquired the prodisc TDR technology platform.\
