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    SEPARATEC

    THE PROBLEM

    A cerebrospinal fluid (CSF) leak is a serious possible complication associated with spinal surgery, especially those involving laminectomies, in which CSF escapes past the arachnoid and dura mater into the epidural space. Most CSF leaks develop during revision surgeries, which occur about 320,000 times in the US each year. In revision surgeries, scar tissue impairs the surgeon's ability to see the surgical site and binds to bone, flesh, and the spinal cord, increasing the probability of puncturing the dura and causing a CSF leak.

    HOW IT WORKS

    Separatec employs ultrasonic vibrations concentrated on a thin, flattened tip in order to separate the scar tissue from bone. The tip is dulled in order to reduce the danger associated with piercing the dura, and the high frequency vibrations allow a surgeon to insert the tool between bone and scar tissue without an excessive amount of force, thereby reducing the risk of applying too much pressure to the dura. Because the dura is more elastic than scar tissue, it is not at risk of being torn by the vibrations the tool emits, and lack of visibility is less of a concern.

    SAFETY

    The current standard of care for dissecting scar tissue in spinal surgeries are periosteal elevators. These devices, designed for general surgical use, are not intended to be used near delicate soft tissue such as the dura, and some elevators, such as the Howarth elevator, have sharp edges that can easily puncture the dura when used to remove scar tissue adhesions. Unlike the current devices on the market, our ultrasonic device has been engineered specifically for use in the spinal region, consisting of both an L-shaped cutting apparatus designed such that it befits the geometry of the spine and a blunted tip to decrease the likelihood of dural tears should it come into contact with the dura.

    ECONOMIC VALUE

    Studies show that out of the 1 million spinal surgeries performed every year, 32% of them will require a revision surgery. Of these 320,000 operations, 18% will result in a dural tear. Each of these 63,000 incidences incurs a cost of $6470 per patient, increasing the financial burden on the healthcare system by around $350 million dollars. Implemenation of Separatec would result in both reduced OR time for surgeons as well as reduced costs for healthcare providers.