SAN CARLOS, Calif.--(BUSINESS WIRE)--Simpirica Spine Inc. developer of minimally invasive, flexion-restricting stabilization devices for the spine, has announced U.S. Food and Drug Administration (FDA) approval to begin an investigational device exemption (IDE) pivotal clinical study of its LimiFlex Spinal Stabilization System. The LimiFlex is a novel dynamic stabilization system designed to address flexion (forward bending) pain and instability without the need for spinal fusion.
The LimiFlex Device IDE clinical study is a prospective, randomized, controlled study enrolling up to 400 patients at up to 35 U.S. centers. Patients will be randomized at a 2:1 ratio to receive either the LimiFlex Spinal Stabilization System or instrumented posterolateral fusion following surgical decompression for the treatment of lumbar degenerative spondylolisthesis with spinal stenosis. Investigators will study the relative safety and effectiveness of the treatments at the time of surgery and through 24 months post-procedure. Results of the study will be used to support a Premarket Approval application to the U.S. FDA for approval of the LimiFlex Spinal Stabilization System.
“The IDE study approval is a significant milestone that will allow us to expand the scientific evidence supporting the LimiFlex Spinal Stabilization System as a new treatment option for patients with degenerative spondylolisthesis,” said Austin Noll, president and chief executive officer of Simpirica Spine. “We look forward to beginning the trial and ultimately having the opportunity to make the system commercially available to U.S. surgeons and their patients.”
Pathological flexion of the lumbar spine can lead to pain or instability for more than 400,000 patients per year worldwide. In patients with lumbar degenerative spondylolisthesis with spinal stenosis, one vertebrae is slipped forward relative to the neighboring vertebrae below it, and the act of bending forward can exacerbate this slip and instability. A concurrent narrowing of the spinal canal puts pressure on the nerves and can cause leg pain, back pain, and sciatica, resulting in significant disability. Today, this condition is most often treated with surgical decompression followed by spinal fusion, an invasive surgical procedure that requires an extended recovery time and can limit spinal motion. Simpirica Spine’s LimiFlex Device is a new treatment alternative designed to address flexion pain and instability in a less invasive manner compared with fusion.
“Flexion is the most important motion of the lumbar spine and is the type of motion most exercised during activities of daily living.1,2 For patients who experience pain and instability during flexion, quality of life can be significantly diminished,” said Dr. Todd Alamin, founder of Simpirica Spine. “The LimiFlex was designed to improve existing standards of care for these patients by providing a minimally invasive and less costly alternative to fusion.”
Multiple clinical studies have been conducted on the LimiFlex Spinal Stabilization System outside of the United States, with one-year follow-up data demonstrating significant reductions in disability and pain as well as segmental stability at the LimiFlex-stabilized level. The LimiFlex is CE marked and has been available commercially in non-U.S. markets since January 2011. To date, hundreds of patients have been treated with the LimiFlex.
The LimiFlex Spinal Stabilization System is an investigational device and is limited by United States law to investigational use only.
About Simpirica Spine Inc.
Simpirica Spine was founded in 2006 to develop minimally invasive, flexion-restricting stabilization devices for the spine. The company’s lead product, the LimiFlex Spinal Stabilization System, is designed to address flexion (forward bending) pain and instability without the need for spinal fusion. LimiFlex is CE marked and available in markets outside of the United States, where it typically is used in conjunction with a surgical decompression for the treatment of lumbar spinal stenosis with or without degenerative spondylolisthesis. The LimiFlex Device provides spinal stabilization for patients who could benefit from additional stabilization in flexion. Simpirica Spine developed and tested its technology over a period of many years with the help of clinical and biomechanical experts from around the world. For more information, please visit www.simpirica.com.
1 Morlock MM, Bonin V, Deuretzbacher G, Müller G, Honl M, Schneider E. "Determination of the in vivo loading of the lumbar spine with a new approach directly at the workplace – first results for nurses." Clin Biomech 2000, 15(8): 549-558.
2 Bible JE, Biswas D, Miller CP, Whang PG, Grauer JN. "Normal functional range of motion of the lumbar spine during 15 activities of daily living." J Spinal Disord Tech. 2010, 23(2): 106-112.