IDE STUDY DATA DEMONSTRATE SHORTER LENGTH OF STAY AND RECOVERY TIME FOR PATIENTS TREATED WITH LIMIFLEX™ DYNAMIC SAGITTAL TETHER™ (DST) STABILIZATION
SAN CARLOS, Calif., June 1, 2023 /PRNewswire/ -- 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 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.
- However, the data showed that compared to TLIF, the DST procedure was shorter, less invasive, and resulted in a faster discharge.
- 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.
- Caution: The LimiFlex Dynamic Sagittal Tether is an investigational device in the United States and is limited by law to investigational use.