Device tested at SUNY Upstate wins FDA approval for use during risky spine or spinal cord surgery
A device tested at SUNY 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, won FDA approval in August and now is available for use in hospitals across the country.
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.
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 last year.
The study involved more than 1,000 patients at the two centers, ranging in ages from 3 to 99. All patients had 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," said SUNY Upstate's Hodge. "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."