U.S. Overview

The LimiFlex Spinal Stabilization System

Simpirica Spine is focusing on the development and commercialization of a new spinal implant that is designed to provide minimally invasive, flexion-restricting, dynamic stabilization. With recent U.S. Investigational Device Exemption (IDE) pivotal study approval, Simpirica Spine is currently identifying potential investigators and clinical sites who would be good partners for its IDE clinical program.

Under the IDE, the company’s lead product, the LimiFlex Spinal Stabilization System, will be studied in conjunction with a surgical decompression for the treatment of lumbar degenerative spondylolisthesis with spinal stenosis. The device is designed to provide spinal stabilization for patients who could benefit from additional stabilization but do not otherwise require fusion. The LimiFlex does not require pedicle screws to anchor to the spine; instead, two dynamic rods are attached by screws to pedicle-sparing straps which encircle adjacent spinous processes.

LimiFlex Device

Biomechanical testing of the LimiFlex on cadaveric specimens was completed by Dr. Avinash Patwardhan of Loyola University. This biomechanical testing showed that the LimiFlex provides segmental stabilization post decompression by (i) reducing flexion range of motion, (ii) increasing flexion stiffness, (iii) increasing facet engagement, and (iv) decreasing segmental translation. Additionally, biomechanical testing completed at UCSF demonstrated that the loads applied by the device are significantly lower than those required to fracture spinous processes, even when up to 50% of a spinous process is removed. Click here for additional detail on the LimiFlex mechanism of action and biomechanical testing.

The LimiFlex™ Spinal Stabilization System provides segmental stabilization by restricting segmental flexion. A complete LimiFlex Device consists of two dynamic titanium rods with attached Ultra-high Molecular Weight Polyethylene (UHMWPE) Straps that wrap around adjacent spinous processes. The attachment mechanisms for the straps are integrated into the rods and allow for intraoperative re-adjustment of the device.

After several years of pre-clinical development, the LimiFlex received the CE Mark in 2009, and surgeons have since implanted the system in over 300 patients. Over 100 of these patients have been enrolled in one of three post-market clinical studies conducted primarily in Europe. Early clinical results are promising and support the company’s marketing and regulatory efforts. European commercialization began in January of 2011 and is progressing well.

In the U.S., Simpirica Spine has finalized its IDE pivotal study design and received pivotal study approval. The pivotal study is a randomized, controlled study in patients suffering from lumbar degenerative spondylolisthesis with spinal stenosis. Patients will be randomized to receive either decompression + LimiFlex or decompression + posterolateral fusion (PLF) and will initially be followed from baseline through to 24 months.

If you are a physician treating patients with degenerative spondylolisthesis and are interested in learning more about the LimiFlex IDE study, please contact Simpirica Spine at clinical@simpirica.com.

United States: CAUTION - Investigational device. Limited by United States law to investigational use.