coflex Interlaminar Technology: Minimally Invasive Non-Fusion Implant

posted in Spinal Stenosis, What's New

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The coflex ® technology is a minimally invasive, non-fusion implant that allows movement of the spine in both flexion and extension, while providing interlaminar stabilization, foraminal distraction and facet distraction. The coflex® is a U-shaped titanium alloy surgical device which is implanted in the interlaminar space following a surgical decompression. The coflex® is being evaluated in the United States for use in patients with moderate to severe spinal stenosis, isolated to 1 or 2 levels, in the region of the first to the fifth lumbar vertebrae, specifically L1 to L5.

The developer of coflex technology is Paradigm Spine, LLC. They have recently announced completion of patient enrollment in an Investigational Device Exemption (”IDE”) pivotal clinical study comparing the coflex® interlaminar technology to instrumented posterolateral fusion in the surgical treatment of spinal stenosis. The study is a prospective, randomized and concurrently controlled clinical study involving more than 380 patients at 21 sites within the United States. Though coflex is only now being studied in the US, the coflex technology, has been in use outside the US for over 15 years of clinical heritage outside the U.S., and has been implanted in more than 50,000 patients internationally.

Dr. Reginald J. Davis, Chief of Neurosurgery at Greater Baltimore Medical Center and an investigator in the study explained, “Since the coflex® device is a functionally dynamic non-fusion implant, it will provide spine surgeons with the option of utilizing a less invasive, tissue sparing procedure while affording patients significant pain relief all without having to resort to fusion. I look forward to having the coflex® device as part of the ‘arsenal’ of surgical options for relief of pain due to spinal stenosis.”

Source
Paradigm Spine, LLC
http://paradigmspine.com/