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Thread: Device Ok'D by FDA for Use During Risky Spine Surgery

  1. #1
    Senior Member Max's Avatar
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    Jul 2001
    Montreal,Province of Quebec, CANADA

    Device Ok'D by FDA for Use During Risky Spine Surgery

    Device Ok'D by FDA for Use During Risky Spine Surgery
    Library: MED
    Description: A device tested at the State University of New York Upstate Medical University has received FDA approval for use in the United States during risky spine surgery.

    For further information contact Doretta Royer, SUNY Upstate Medical University Public Relations at 315-464-4833 or

    A device tested at State University of New York Upstate Medical University has received FDA approval for use in the United States during risky spine or spinal cord surgery.

    SUNY Upstate's Blair Calancie, Ph.D., professor of neurosurgery, was the only investigator in the United States granted permission by the FDA to use the device in a clinical trial. The device, known as the Digitimer D185 MultiPulse Cortical Stimulator, is the newest generation of stimulators to help neurosurgeons monitor a patient's central nervous system during risky spine or spinal cord surgery. The device, produced by Digitimer Ltd. Of Herfordshire, England, was approved by the FDA in August paving the way for its use in hospitals across the United States.

    The box-like device looks much like one used by hospitals to collect data on vitals, such as blood pressure and temperature. However, the D185 box is attached to two electrodes. After the patient undergoes general anesthesia, the electrodes are placed on the patient's scalp overlying that part of the brain, known as the motor cortex, that controls voluntary movements. Brief electrical pulses delivered through these electrodes activate nerves in the motor cortex, sending nerve signals down the spinal cord, across the region at risk by the surgery.

    Muscles of the arms and legs respond with brief contractions, indicating the signals are getting through. Changes in these muscle responses to stimulation may indicate deterioration in nerve conduction, thus alerting the surgeon that the procedure being performed could potentially cause a loss of strength (i.e. paralysis) after surgery.

    "The device allows neurosurgeons and their teams to monitor spinal cord function, specifically the part that controls voluntary movements of the arms and legs, in patients who are undergoing surgical procedures that place the spinal cord at risk," Calancie said. "If the electrical pulsations indicate that what the surgeon is doing could potentially harm the patient, the surgeon can then stop the procedure and determine the next course of action. If the test results shows that injury will not be a factor, the surgeon can then be more aggressive in the current course of surgical repair."

    Calancie's findings provided the proof the FDA needed to approve the marketing of the device. His findings demonstrated that the use of the device showed a reduction in serious complications post-surgery and can lead to improved quality of life for some patients. The FDA approved the device for use in the United States in August.

    Calancie's seven-year study began at the University of Miami's Department of Neurological Surgery and the Miami Project to Cure Paralysis, and continued at SUNY Upstate when he joined the Department of Neurosurgery in August 2001.

    The study involved more than 1,000 patients at the two centers, ranging in ages from 3 to 99. All patients underwent surgery involving the spine and /or spinal cord, such as operations to remove tumors or to correct scoliosis. There were no serious side effects of stimulation, and even minor complications were few in number.

    At SUNY Upstate, Calancie worked cooperatively with Charles Hodge, M.D., chairman of the Department of Neurosurgery. Calancie's Miami associates were Barth Green, M.D., professor and chair of Department of Neurological Surgery and president of the Miami Project to Cure Paralysis; Dalton Dietrich, Ph.D., scientific director of the Miami Project; and William Harris, Guillermo Pineiro, Jenna Savage, Robert Lampman and Maria Molano, M.D. of the University of Miami.

    "We are very excited about the results of Dr. Calancie's study. The device not only offers us an optimal way to monitor our patients, but it also provides us the feedback we need to ensure quality patient care. Through the recent FDA approval, the device can now aid other neurosurgeons across the country," said SUNY Upstate's Hodge.

    SUNY Upstate is part of the State University of New York and is located in Syracuse.


    "It was once written "To thine own self be true". But how do we know who we really are? Every man must confront the monster within himself, if he is ever to find peace without. .." Outer Limits(Monster)

  2. #2
    Reducing the risks: Monitor helps prevent surgical spinal cord injuries
    Rating: テつ* Not yet ratedAuthor Topic: テつ* Reducing the risks: Monitor helps prevent surgical spinal cord injuries


    Member posted Oct 07, 2002 02:53 PM テつ*
    Reducing the risks: Monitor helps prevent surgical spinal cord injuries

    October 07, 2002

    By Amber Smith Staff writer

    People who undergo spinal surgery are at risk for loss of strength, loss of sensation, or increase of pain after their operations.

    Blair Calancie is helping to reduce those risks.

    From Our Advertiser

    He sends tiny electrical shocks through a needle placed beneath the skin above either ear. As surgeons work, removing a tumor or straightening a curved spine, Calancie assesses their moves. When he stimulates the left needle, the muscles on the patient's right side will contract - or should.

    If they don't, Calancie alerts surgeons.

    Maybe a blood vessel is blocked, or a rod is pressing on the spinal cord. Something is blocking nerve transmission, Calancie explains, "and if nothing is done, the patient will wake up paralyzed."

    Calancie, who joined SUNY Upstate Medical University last year as a professor of neurosurgery, says the multipulse cortical stimulator device called the Digitimer can prevent surgical spinal cord injury. It significantly improves the quality of monitoring available for spinal surgery patients - especially those undergoing the riskiest procedures.

    "Very quickly we were able to es tablish that in this population, if we saw signal changes using our technology, in every case the person after surgery had weakness confirming our signal changes," Calancie says of his early work at the University of Miami.

    He obtained permission from the Food and Drug Administration in 1988 to experiment with the device. Soon the surgeons in Miami were hooked. If the monitor was not available for certain operations, they canceled the operations, Calancie says.

    An article Calancie wrote in the Journal of Neurosurgery in March 1998 explained how surgeons performing tumor resections or correcting vascular abnormalities or major deformities "should benefit from the virtually immediate and accurate knowledge of spinal motor conduction provided by this new monitoring approach."

    He brought the technology with him to Upstate, expanding his FDA protocol. The federal regulatory agen cy approved the Digitimer last month, so surgeons throughout the country are likely to start using it.

    Calancie tailors the device to each patient. If someone is having surgery on the neck region, he knows the hands and arms are most at risk, and he'll send shocks designed to evoke contractions of those muscles. If someone is having surgery at the base of his or her spinal cord, Calancie will concentrate on the muscles of the legs.

    "This has lead to a fundamental change in what monitoring allows us to do," he says.

    Surgeons can be more aggressive in removing a tumor. They can be more aggressive in straightening a spine curved by scoliosis. They can stop at any time and ask Calancie, "Have the signals changed?"

    He can send some shocks and report, with confidence, "No, everything is fine." And whatever the surgeon was doing, he or she can continue.

    "It's a nuance of the monitoring that on the one hand seems subtle," Calancie admits. "But on the other, the doctors are very quick to pick up on, 'Hey, I can get a little more out of this. I can trust this monitoring.'

    "That's what happened in Miami."

    テつゥ 2002 The Post-Standard. Used with permission.

    "Events in our past seem to slip further away with time. But what happens when they circle back and meet us head the present? Before we allow ourselves to be consumed by our regrets, we should remember the mistakes we make in life are not so important as the lessons we draw from them.." Outer Limits(Last supper)

    Posts: 2742テつ*|テつ*From: Montreal,Province of Quebec, CANADAテつ*|テつ*Registered: Jul 25, 2001
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  3. #3

    device approved

    Max - thank you for sharing this new information; hopefully this will begin being used with increasing frequency. There are so many persons whose surgery on their backs and spines has only caused them more pain and disability than the condition that warranted the surgery. CRF

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