NORWALK, Conn., Feb. 8, 2024 /PRNewswire-PRWeb/ — In a significant development, Premia Spine, a leading medical device company, has unveiled the results of a groundbreaking study published in The Spine Journal, reaffirming the cost-effectiveness and superiority of their Total Posterior Spine (TOPS™) System. This study, titled “A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis,” presents a comprehensive evaluation based on an updated FDA investigational device exemption (IDE) dataset. Read Full Study Here: The Spine Journal
The study’s purpose was to assess the cost-effectiveness of the TOPS™ System in comparison to transforaminal lumbar interbody fusion (TLIF) with a focus on an expanded dataset and pricing considerations. Conducted as a multicenter, FDA IDE, randomized control trial (RCT) with 305 enrolled subjects, the study yielded significant insights.
Key findings from the study include:
- Increases in healthcare costs will inevitably result in additional strain on both the patient and collective healthcare system. The current trajectory estimates an increase in healthcare-related costs from $4.3 trillion dollars in 2021 to $6.2 trillion dollars by 2028. Source: National Health Expenditure Data: Historical. Centers for Medicare & Medicaid Services, September 10, 2021 (Accessed).
- Innovative interventions tend to be considerably more costly than the current standards they seek to replace. A series of complex analyses and processes tend to follow for the ‘system’ to determine if this is a sustainable and meaningful alternative. It is exceedingly uncommon for novel technology, such as the TOPS™ System, to provide improved quality of life at a lower long-term cost. Although still early, TOPS™ certainly appears to be a healthcare economic discovery.
- This study shows a continued longitudinal improvement in cost-effectiveness over time with the TOPS™ device appearing to be overwhelmingly cost-effective, and immediately and longitudinally dominant compared to TLIF and should be considered a highly viable option for appropriate patients.
The updated analysis consistently demonstrates the immediate and long-term dominance of the TOPS™ System over the control (TLIF), with a remarkable ICER of -$9,637.37 $/QALY and a Net Monetary Benefit (NMB) of $2,237 at the 2-year mark from the health system’s perspective and a WTP threshold of $50,000 $/QALY. These findings remain robust across all scenarios tested, reaffirming the TOPST™ System’s cost-effectiveness.
Furthermore, alternative sensitivity analyses support its cost-effectiveness, regardless of payer type or surgical setting. To maintain this cost-effectiveness, the cost difference between TOPS™ and TLIF should not exceed $1,875 and $3,750 at WTP thresholds of $50,000 and $100,000 $/QALY, respectively. Overall, this updated analysis solidifies the TOPS™ System as a highly cost-effective and dominant surgical option for patients with lumbar stenosis and degenerative spondylolisthesis, offering significant benefits to both healthcare systems and patients alike.
About Premia Spine
Premia Spine, a medical technology company, is committed to enhancing the quality of life for patients suffering from chronic leg and back pain. Its products are specifically designed to offer durability, stability, and increased mobility to those struggling with lumbar spinal stenosis, degenerative spondylolisthesis, and related spinal conditions. The TOPS System, Premia Spine’s flagship product, has received the CE mark and has now obtained approval for distribution within the United States.
Media Contact
Peter Wherly, Premia Spine, 1 (303) 324-4933, PeterW@premiaspine.com, https://premiaspine.us
SOURCE Premia Spine