In 2021, Empirical Spine hit multiple milestones for its Limiflex dynamic sagittal tether.
Limiflex is a device for grade 1 lumbar degenerative spondylolisthesis patients with spinal stenosis, according to a Feb. 1 news release. It's designed to preserve motion and stability after an open lumbar decompression.
Three key milestones:
1. Limiflex received FDA breakthrough device designation, providing the company with expedited review timelines and increased communication with the agency.
2. Empirical Spine began its premarket approval for Limiflex. The first module was submitted, and the remaining two will be added in the coming months.
3. Outcomes from an investigational device study were presented in November. The study concluded Limiflex showed similar improvement in disability compared to those who had a transforaminal lumbar interbody fusion.