Information reveals important superiority of TOPS aspect joint alternative system over TLIF fusion in treating degenerative spondylolisthesis with stenosis.
NORWALK, CONN. (PRWEB) JUNE 20, 2023 – Premia Backbone, a medical expertise firm revolutionizing the remedy of continual leg and again ache, proudly pronounces the Food and Drug Administration (FDA) approval of its Complete Posterior Backbone (TOPS) aspect joint alternative system. The TOPS System beforehand earned the FDA’s Breakthrough Designation standing and has now efficiently accomplished its Premarket Approval (PMA) software. Premia Backbone undertook rigorous testing to obtain FDA approval, together with an Investigational Machine Exemption (IDE) examine to substantiate the protection and efficacy of the system. The corporate’s pivotal FDA trial demonstrated that, at two years post-operation, the TOPS System outperformed fusion in treating grade 1 degenerative spondylolisthesis with stenosis. This accomplishment marks the TOPS System as the primary lumbar spine implant to obtain a superiority declare over lumbar fusion.
The examine’s information revealed that the TOPS arthroplasty group considerably surpassed the TLIF fusion group in general medical success, with a 77% success charge in comparison with 24% respectively. Whereas each arthroplasty and fusion strategies stabilized the spine section, the TOPS aspect alternative preserved movement on the index stage, resulting in fewer problems and reoperations. Moreover, sufferers who underwent TOPS arthroplasty reported improved outcomes in areas akin to each day perform and ache ranges in any respect assessed time factors. Notably, the hole in these enhancements between the 2 teams expanded over time, turning into extra pronounced from six months to 24 months postoperatively.
This landmark examine aimed to reveal the medical superiority of the TOPS System by randomizing sufferers at a 2:1 ratio to endure both aspect arthroplasty or TLIF fusion. The examine was carried out throughout 37 facilities, reinforcing its complete and numerous surgeon and affected person base. The first final result success was evaluated in a complete of 168 topics (115 TOPS arthroplasty and 53 TLIF fusion) on the two-year mark. The information revealed a big benefit for the TOPS System over fusion in a number of areas: each day perform enchancment, with 95% success for TOPS arthroplasty versus 79% for TLIF fusion as per the Oswestry Incapacity Index; charges of latest or worsening neural deficit, with 3% for TOPS arthroplasty versus 12% for TLIF fusion; charges of postoperative injections or surgical interventions, with 11% for TOPS arthroplasty versus 23% for TLIF fusion; and charges of movement or fusion failure, at a considerably decrease 1% failure for TOPS arthroplasty versus 44% failure for TLIF fusion.
“The outcomes of this examine validate our speculation that TOPS lumbar aspect arthroplasty yields a better charge of medical success and fewer revision procedures in comparison with fusion,” acknowledged Ron Sacher, CEO of Premia Backbone. “With FDA approval now secured, our precedence shifts to making sure entry to the TOPS System for the numerous people dwelling with spinal stenosis and spondylolisthesis.”
TOPS options two cross bars that affix to pedicle screws and a central movement mechanism, positioned after bilateral facetectomies. The TOPS movement system is designed to permit widened decompression of the neural components, stabilization of the spondylolisthesis, and preservation of movement in all ranges of movement.
The preliminary outcomes of the possible, randomized, multi-center FDA trial, titled “Potential, Randomized and Managed Multicenter Research of Posterior Lumbar Side Arthroplasty for the Therapy of Spondylolisthesis” have been printed within the Journal of Neurosurgery Backbone.
“The information from our two-year evaluation confirms our premise – there’s certainly a viable different to fusion for sufferers battling the ache and debility of lumbar spinal stenosis and degenerative spondylolisthesis,” acknowledged Danny Bejarano, Chairman of Premia Backbone. “The TOPS System, has surpassed fusion – the present gold customary – and may now declare its superiority primarily based on Stage I medical proof.”
TOPS stands as the primary and solely aspect joint alternative system for the lumbar spine, designed to protect mobility after decompression in sufferers affected by lumbar spinal stenosis and degenerative spondylolisthesis. These painful and debilitating situations have an effect on over 100 million people globally1. Yearly, an estimated 350,000 individuals endure lumbar spinal fusion for these conditions2, equivalent to a possible $2 billion annual market globally.
About Premia Backbone
Premia Backbone, a medical expertise firm, is dedicated to enhancing the standard of life for sufferers affected by continual leg and again ache. Its merchandise are particularly designed to supply sturdiness, stability, and elevated mobility to these battling lumbar spinal stenosis, degenerative spondylolisthesis, and associated spinal situations. The TOPS System, Premia Backbone’s flagship product, has acquired the CE mark and has now obtained approval for distribution inside the USA. Go to PremiaSpine.com to study extra.
References:
[1] Ravindra, V. M., et al. Degenerative Lumbar Backbone Illness: Estimating International Incidence and Worldwide Quantity. International Backbone Journal: 2018, Vol 8, Concern 8. https://journals.sagepub.com/doi/full/10.1177/2192568218770769
[2] 2019 Spinal Surgical procedure Replace. Orthopedic Community Information: Quantity 30, Quantity 4, October 2019.
Discussion about this post