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 intraoperativere-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.
- Typical 15 minute implantation time
- Reduced overall procedure time compared with pedicle screw based fi xation systems 1,2
- One size: Novel adjustable band locking mechanism allows adjustment to patient size and anatomy
- Band fi xation results in less procedural morbidity compared to pedicle screw fi xation 1,3,4
- The LimiFlex™ Paraspinous Tension Band is designed to work in parallel with ligaments and
- facets, and utilizes low forces to minimize loads on the anatomy 5
- The LimiFlex™ Paraspinous Tension Band maintains sagittal lordosis while preventing progressive slipand translation
United States: CAUTION – Investigational device. Limited by United States law to investigational use.
About Interspinous Devices
Interspinous spacers sometimes also called as Interspinous process decompression systems, are the devices implanted between vertebral spinous processes. These spacers are made up of a very strong but lightweight metal (titanium) which is biocompatible in the human body. These devices are imbedded in body to confine painful motion else enabling normal motion and to treat lumbar spinal stenosis, discogenic low-back pain, facet syndrome, disc herniations, and non-traumatic instability. Lumbar spinal stenosis is a thinning of the spinal canal in the lower back which causes compression on nerves and it is developed gradually with age. Radiology tests are used to confirm a diagnosis of moderate degenerative lumbar spinal stenosis. People with lumbar spinal stenosis experience pain but may also have weakness in their leg, lower back and buttocks, numbness, tingling.
The Interspinous spacer are implanted between those vertebrae in such a way that it prevents the patient from bending too far backward which causes pain by surgical procedure. The procedure is very small and sometimes patient can go home within a day.The increasing prevalence of spinal stenosis due to aging, arthritis, heredity and increased demand of surgical procedures that improved lifestyle and comfort will drive the Interspinous spacer market. The adoption of spacers are increasing due to low complication rate as compared to decompression and spinal fusion. The Interspinous spacers are widely used in geriatric population as per Medicare data due to old age patient are not comfortable with surgery due to their health conditions. Source:Transparency Market Research (TMR)
About Simpirica Spine
Simpirica Spine, Inc. was founded in 2006 to develop minimally invasive, flexion-restricting stabilization devices.The potential for this novel stabilization approach is tremendous. Flexion, or forward bending, of the lumbar spine can lead to pain or instability for over 400,000 patients per year worldwide.Outside the U.S., the company’s lead product, the LimiFlex Spinal Stabilization System, has a CE Mark and is approved for distribution in the European Union, where it is typically used in conjunction with a surgical decompression for the treatment of lumbar spinal stenosis with or without degenerative spondylolisthesis.In the U.S., safety and effectiveness of the LimiFlex Spinal Stabilization System will be evaluated in a randomized study in which patients will undergo surgical decompression followed by stabilization with either the LimiFlex Device or fusion for the treatment of lumbar spinal stenosis with degenerative spondylolisthesis.The Simpirica team is dedicated to fulfilling the promise of flexion-restricting stabilization and to improving clinical outcomes for patients and surgeons around the globe.http://www.simpirica.com