The Bethlehem, Pa.-based St. Luke's University Health Network is six months into a clinical study on a neuro-stimulation implant known as Burst during spinal cord stimulation surgery, reports Lehigh Valley Business.
In a year's time, officials with St. Luke's said, they expect the FDA to greenlight the device.
"Basically, we put an electrode on the spine," said Steven M. Falowski, MD, a neurosurgeon with St. Luke's. "Normally, with this kind of surgery we stimulate nerves that are creating pain. So, patients would get a tingly sensation. With the new device, a patient gets the pain relief without the tingling or any other sensation."
So far, Dr. Falowski said he's implanted the device into five patients, who have all cut their pain medication in half or not longer take it at all. He added that he hopes to get 10 to 15 more patients to agree to enroll in the study over the next months.
Officials with St. Luke's credited Dr. Falowski as being one of the biggest reasons the healthcare provider was able to proceed with the study — and, for his part, Dr. Falowski said he is happy with the study, and the results of the device, so far.
"This is not a last-resort therapy. It is an in-and-out surgery that gives comfort to people who are in extreme chronic pain for a long time," he said. "We help people with a disability get back to work. We give them back their quality of life."
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