IDE Study Data Demonstrate Shorter Length of Stay and Recovery Time for Patients Treated with Limiflex™ Dynamic Sagittal Tether™ (DST) Stabilization

Decompression Surgery with DST Stabilization May Be Viable Alternative to Transforaminal Lumbar Interbody Fusion (TLIF) for Degenerative Spondylolisthesis 

San Carlos, Calif. (June 1, 2023) – A recently published paper in The Open Orthopaedics Journal compared outcomes for degenerative spondylolisthesis surgery using decompression and Empirical Spine’s LimiFlex™ Dynamic Sagittal Tether™ (DST) stabilization versus transforaminal lumbar interbody fusion (TLIF). The interim results of the FDA IDE trial showed both approaches led to substantial improvements in pain and function within the initial postoperative period, but the DST group had shorter hospital stays, earlier return to work, and higher patient-reported activity levels three months post-surgery.

The paper, entitled “Initial Perioperative, Work Status, Activity and Safety Outcomes after Decompression and Dynamic Sagittal Tether Stabilization versus Transforaminal Lumbar Interbody Fusion for Degenerative Spondylolisthesis: Interim Results from an FDA IDE Trial,” was written by a team of researchers led by William F. Lavelle, M.D., of SUNY Upstate Medical University, Rick C. Sasso, M.D., of Indiana Spine Group, and William C. Welch, M.D., of the University of Pennsylvania.

The analysis evaluated the 90-day outcomes of IDE study patients who received the LimiFlex DST versus TLIF stabilization after decompression surgery for degenerative spondylolisthesis, a condition in which a vertebra slips forward on the vertebra below it, causing pain, numbness, and weakness. In addition to the improvements in pain and function, the results demonstrated that both approaches had no significant differences in perioperative complications or adverse effects within the initial postoperative period. However, the data showed that compared to TLIF, the DST procedure was shorter, less invasive, and resulted in a faster discharge. Also, for the DST group, faster recovery, return to work, and activity levels were noted.

“These interim results suggest that decompression and DST stabilization may be a viable alternative to TLIF for patients with degenerative spondylolisthesis, offering comparable outcomes with potential benefits in terms of hospital stay, return to work, and activity levels,” said Dr. Lavelle.

The paper adds to the growing body of literature on DST, a novel surgical device that uses a flexible tether designed to stabilize the spine and allow controlled motion, as opposed to rigid fusion. The FDA IDE trial is ongoing, and further data will be collected and analyzed to assess the long-term outcomes of decompression and DST stabilization versus TLIF.

About LimiFlex™

LimiFlexTM is the first-in-class Dynamic Sagittal Tether™ (DST), designed to maintain motion and stability after spinal decompression, without contributing to adjacent level issues, for grade 1 lumbar degenerative spondylolisthesis patients with spinal stenosis. By augmenting the posterior tension band, LimiFlex creates elastic resistance to flexion and maintains lordosis. For the first time, patients and surgeons will have a minimally invasive option that is designed to allow relief of neuro-compressive pain without compromising segmental motion. LimiFlex is compatible with current decompression techniques and can be performed in an outpatient setting, typically in less than 20 minutes. LimiFlex does not involve any screws or bone grafts, which can cause issues by eliminating the natural motion between spine segments and compromising options for other treatments if needed.

About Empirical Spine

Empirical Spine, Inc., founded in 2015, is a privately held company creating a new standard of care in spine surgery that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life. The company’s LimiFlex™ Dynamic Sagittal Tether™ (DST) is the first-of-its-kind surgical option for degenerative spondylolisthesis patients that no longer forces the trade-offs in outcomes and costs that lumbar fusion creates. LimiFlex is a minimally invasive implant designed to stabilize the spine after open decompression, while preserving motion. The company is currently concluding a pivotal IDE trial in the U.S. For more information: https://www.limiflex.com/.

Caution: The LimiFlex Dynamic Sagittal Tether is an investigational device in the United States and is limited by law to investigational use.