The North American Spine Society (NASS) 2023 conference held in Los Angeles was abuzz with excitement, bringing together spine specialists, medical device manufacturers, and healthcare enthusiasts from around the world. Amidst the bustling atmosphere of the event, Doctech.live, a prominent Med-Tech Innovation Report and journalist company sponsored by Ghost Productions Inc., had the unique opportunity to interview Todd Alamin, a representative from Empirical Spine. This conversation shed light on LimiFlex’s groundbreaking medical device, the Dynamic Sagittal Tether™, which is poised to revolutionize the treatment of degenerative spondylolisthesis.
LimiFlex: A Beacon of Hope for Spinal Health
Empirical Spine, a medical device company, has introduced the first and only Dynamic Sagittal Tether™, a modern, minimally invasive, and motion-preserving option for patients suffering from degenerative spondylolisthesis. This condition, characterized by the forward slippage of one vertebra over another, often leads to nerve compression, resulting in severe pain and disability. Traditionally, this ailment was treated with spinal fusion surgery, a procedure known for its invasiveness, costliness, and risk of complications.
The Dynamic Sagittal Tether™ offers a potential alternative to spinal fusion, and Todd Alamin shared valuable insights into how this innovative device came to be and its potential benefits for patients.
The Birth of a Revolutionary Idea
Todd Alamin explained that the concept behind the Dynamic Sagittal Tether™ initially aimed to restore the tension band in the spine’s posterior region. However, it soon became evident that this approach had clinical utility in addressing a range of conditions, with degenerative spondylolisthesis being a primary focus. This condition, characterized by the slipping of one vertebra over another, often results in nerve compression, making it a significant challenge for both patients and physicians.
Traditional treatment in the United States involves fusion surgery, combining fusion with decompression to manage instability and nerve compression. LimiFlex set out to offer a different approach to addressing this issue.
A Game-Changer for Patients
The Dynamic Sagittal Tether™ relies on two key factors: the surgeon’s ability to perform direct decompression to relieve nerve pressure, and the body’s natural stability when the spinal segment is in an extended position. This device, already approved in Europe, is currently under evaluation by the FDA for approval in the United States. To meet the FDA’s stringent requirements, LimiFlex conducted a comprehensive clinical trial involving 300 participants, with two years of follow-up, including a control group undergoing lumbar fusion.
One of the most exciting aspects of the Dynamic Sagittal Tether™ is its ability to preserve motion and anatomy. It repositions the affected segment to engage the facet joints, creating spinal stability without the need for fusion. As Todd Alamin shared, approximately two-thirds of patients in their clinical trial were able to return home the same day, and 90% within two days, underscoring the device’s minimally invasive nature.
A Bright Future for Spinal Care
In the interview, Todd Alamin discussed the potential longevity of the Dynamic Sagittal Tether™ and its ability to enhance patients’ quality of life. While the device may not be suitable for young adults or those with immature skeletons, it offers hope for countless individuals suffering from degenerative spondylolisthesis.
Beyond motion preservation, LimiFlex’s approach offers faster recovery times and outpatient procedures, in stark contrast to the lengthy hospital stays often associated with spinal fusion surgery. Additionally, the device may help mitigate the risk of adjacent segment degeneration, a concern for fusion patients.
As the interview concluded, Todd Alamin’s words resonated with the promise of LimiFlex: “The big benefit immediately is how much faster they recover and that it’s an outpatient procedure. And then longer term, the prospect that we’re avoiding adjacent segment degeneration sort of annuity that fusion patients become.”
With its potential to transform the landscape of spinal care, LimiFlex’s Dynamic Sagittal Tether™ represents a beacon of hope for those suffering from degenerative spondylolisthesis and paves the way for a brighter future in spinal health.