CAUTION: This device is an investigational device and is limited by United States law to investigational use only. It is not approved for commercial sale or distribution.
Restore is a surgical implantable lumbar facet joint replacement device designed to mirror the spine's natural anatomy. It provides stability while maintaining physiologic motion and function, offering a superior alternative to lumbar fusion procedures. The device allows for straightforward implantation and is ideally suited for minimally invasive surgical techniques.
An estimated 900,000 patients undergo spinal surgery each year. When surgery is required to treat debilitating low back pain and sciatica, it often takes the form of a lumbar fusion. This procedure provides lumbar stability, but at the expense of motion.
The introduction of a fused, non-mobile segment creates a bio-mechanical "disconnect," with the fusion forcing the spine not to move where fusion was performed. This can accelerate degenerative changes at the mobile segments above or below the fusion.
An artificial "back joint", designed upon the natural lumbar facet joint anatomy, to work in concert with the rest of the spine in providing stability and motion.
Our investigational device outperformed efforts by previous devices, all of which were bilateral devices, in scientific human cadaveric assessments.
As Restore is a unilateral device, it is smaller, facilitating minimally invasive surgical techniques.
(Image is a prototype)
Unlike other treatment models on the market, Restore is designed to work in concert with the rest of the spine. There was 40% less force application at the screw-bone interface with Restore in our cadaveric tests, when compared to the only commercially available facet replacement device.
The design mirrors the natural anatomy of a human lumbar facet joint.
We met with the FDA on two separate occasions. We know the exact pre-clinical tests we must perform, and that we will need to run a national, multi-center, pivotable IDE clinical study in order to gain approval to enter the U.S. Market.
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