Empirical Spine: PMA Module II for LimiFlex Submitted

Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently submitted Premarket Approval (PMA) Module II in the US Food & Drug Administration (FDA) approval process for its LimiFlex™ Dynamic Sagittal Tether™ (DST).

LimiFlex is an investigational device targeting grade 1 lumbar degenerative spondylolisthesis patients with spinal stenosis. It is designed to restore natural segmental motion and stability after lumbar decompression by augmenting the posterior tension band. This creates elastic resistance to flexion and maintains lordosis, giving patients the stabilization their spines need while preserving normal motion. The Dynamic Sagittal Tether is intended to be an alternative to spinal fusion, which has persistent and well-documented drawbacks, including being highly invasive and expensive and carrying a high risk of surgery-related complications and re-operations.

LimiFlex uses a novel design that works with the body’s natural anatomy to provide the incremental stability needed by maintaining lordosis and encouraging facet engagement. Unlike interspinous spacers, LimiFlex only engages when a patient bends forward, which avoids delivering excess force and stress on the spinous processes with each step. LimiFlex was designed to act as a ligament to augment the natural anatomy after a thorough decompression for the stenosis. It is compatible with current decompression techniques and is inserted without screws to reduce procedural morbidity and preserve the option for other treatments if needed.

“Empirical Spine continues to make advances to bring LimiFlex to market in the coming months. This is an exciting development for patients looking for an alternative to spinal fusion to relieve the negative effects of degenerative spondylolisthesis that can greatly compromise their quality of life, ” said Richard Treadwell, President and CEO of Empirical Spine. “We expect to submit PMA Module III in mid-summer, and LimiFlex has already received FDA’s Breakthrough Design Designation for its significant advantages over existing approved or cleared treatment alternatives.”

Key potential benefits of LimiFlex cited in the Breakthrough Design Designation application include:

  • Fast and easy implantation that is less invasive
  • Shorter surgery that can be performed in an outpatient setting, reducing or eliminating a hospital stay
  • Improved intra- and post-operative outcomes
  • Improved quality of life
  • Motion preservation at the affected spinal level

Degenerative spondylolisthesis is a condition that disproportionately affects people over age 65, particularly women.

LimiFlex received the CE Mark in 2009 and has been implanted with excellent results in more than 2,000 European patients. Results to date, including this 10-year experience, show the potential for LimiFlex to provide a robust, motion-preserving, minimally invasive, outpatient solution.

Currently, an estimated 140,000 patients receive lumbar fusion annually for degenerative spondylolisthesis in the US alone. Despite reported results superior to standalone decompression, instrumented fusion remains an invasive surgical option not appropriate or desirable for many patients due to its longer recovery time and postoperative complications. Post-fusion rates of adjacent segment degeneration, just one important sequela that can lead to additional fusion surgery, range from 30-50% in the literature.

LimiFlex also is economically favorable over fusion. With payer policies shifting toward lower cost-of-care settings, it is predicted that by 2028, 85 percent of all surgeries will be performed in outpatient settings. In fact, 50 percent of lumbar decompressions have already shifted to a lower cost-of-care setting like ambulatory surgery centers (ACS).

About LimiFlex

The LimiFlexTM is the first-in-class Dynamic Sagittal Tether (DST) and is 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 band, LimiFlex creates elastic resistance to flexion and maintains lordosis. For the first time, patients and surgeons will have a minimally invasive option that relieves compressive pain without compromising segmental motion. LimiFlex 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.

About Empirical Spine

Empirical Spine, Inc., founded in 2015, is a privately held company creating a new standard in spine surgery that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life. The company is currently running a pivotal IDE trial in the US on its breakthrough LimiFlex™ Dynamic Sagittal Tether. LimiFlex is a minimally invasive implant designed to stabilize the spine after open decompression, while preserving motion.

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