Empirical Spine recently submitted premarket approval (PMA) Module II in the US Food and Drug Administration (FDA) approval process for its LimiFlex Dynamic Sagittal Tether (DST).
LimiFlex is an investigational device targeting grade one 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 stabilisation their spines need while preserving normal motion, according to the company.
The DST is intended to be an alternative to spinal fusion, which Empirical Spine say has persistent and well-documented drawbacks, including being highly invasive and expensive and carrying a high risk of surgery-related complications and reoperations.
The company adds that 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 president and CEO, Richard Treadwell, said: “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.
“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.”
LimiFlex received the CE Mark in 2009 and has been implanted in more than 2,000 European patients to-date.