- The Patient Access Program has been developed and will be administered in conjunction with MCRA, a leading healthcare industry advisory firm - The program will expand reimbursement support for two-level prodisc® L Lumbar Total Disc Replacement procedures - prodisc® L is the only total disc replacement system in the world approved for two-level use in the lumbar spine
| WEST CHESTER, Pa., Oct. 27, 2020 /PRNewswire/ -- Centinel Spine Inc.®, LLC, the largest privately-held spine company focused on anterior column reconstruction, today announced the launch of the Patient Access Program, a program designed to further expand patient access to the prodisc® L Lumbar Total Disc Replacement (TDR) system. The Patient Access Program will be particularly focused on providing reimbursement support for two-level lumbar disc replacement procedures using prodisc® L, the only lumbar TDR product in the world that is FDA-approved for two-level use.
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 demonstrates 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. About Centinel Spine, LLC Centinel Spine®, LLC is the largest privately-held spine company focused on anterior column reconstruction. The company offers a continuum of trusted, brand-name, motion-preserving and fusion solutions backed by over 30 years of clinical success—providing the most robust and clinically-proven technology platforms in the world for total disc replacement (prodisc®)and Integrated Interbody™ fusion (STALIF®). Today, Centinel Spine advances its pioneering culture and continues its corporate mission to become the worldwide leading company addressing spinal disease anteriorly with the widest breadth & depth of technology platforms. Centinel Spine stands alone as the only company with comprehensive motion-preserving and fusion solutions for both cervical and lumbar anterior column reconstruction. In June, 2019, the company entered into partnership with professional athlete Tiger Woods. Woods underwent spinal fusion surgery using Centinel Spine’s STALIF M-Ti™ Anterior Lumbar Integrated Interbody fusion product in April 2017 to alleviate ongoing, debilitating pain in his back and legs. Centinel Spine derived its name from the “Sentinel Sign”, the radiographic confirmation of a successful fusion anterior to the interbody device. For more information, please visit the company’s website at www.CentinelSpine.com or contact: Varun Gandhi
SOURCE Centinel Spine, LLC |
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