What To Know
- New developments to the family of products include a recently initiated two-level 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.
- Patient Access Program will be particularly focused on providing reimbursement support for two-level lumbar disc replacement procedures using prodisc® L, the only lumbar Total Disc Replacement product in the world that is FDA-approved for two-level use.
October 27, 2020
Patient Access Program will be particularly focused on providing reimbursement support for two-level lumbar disc replacement procedures using prodisc® L, the only lumbar Total Disc Replacement product in the world that is FDA-approved for two-level use. The news was announced today by Centinel Spine.
In April, Centinel Spine announced FDA approval of two-level indications for the prodisc® L Lumbar Total Disc Replacement (TDR) system. This expanded indication allows for the treatment of a significant number of patients who suffer with two-level Degenerative Disc Disease and were not previously able to gain access to the technology. Long term data from FDA studies demonstrate that lumbar total disc replacement maintains spinal motion, decreases the occurrence of adjacent segment disease, and allows for faster recovery and return to activities of daily living.
The Patient Access Program has been developed and will be administered in conjunction with Musculoskeletal Clinical Regulatory Advisors (MCRA), a leading healthcare industry advisory firm founded in 2004 and serving more than 500 clients worldwide. MCRA is known for successfully navigating complex global reimbursement pathways for new technologies. The program will support reimbursement coding questions and the case management process on behalf of providers and patients, advocating for patient access throughout the benefit verification, prior authorization and appeals processes.
“The Patient Access Program is here to provide patients the benefit of covered access to a motion-preserving technology clinically proven over the last 30 years,” stated Centinel Spine CEO Steve Murray. “We have been encouraged by the continued progress in expanded coverage for single-level lumbar TDR procedures, and continue work to advance these same coverage benefits for patients with two-level disc disease,” Murray concluded.
Centinel Spine stands alone as the only company with FDA-approved cervical and lumbar total disc replacement devices. 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 two-level 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.