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The Senza System can reduce pain without producing a tingling sensation called paresthesia by providing high frequency stimulation (at 10 KHz) and low stimulus amplitudes.

"The FDA has approved several other totally implanted spinal cord stimulators for pain reduction, yet this system is unique because it provides a high frequency output of 10 kHz that doesn't create a tingling sensation--called 'paresthesia'--in patients," said William Maisel, M.D., M.P.H., temporary director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health. "Since some patients don't enjoy the paresthesia associated with traditional SCS, this device offers another treatment alternative."

Back pain is a common impairment for several Americans. Intense pain starts suddenly and is usually not dull in quality. Severe pain could be light and last only a minute, or it could be serious and may last three to six months. In most cases, intense pain disappears when the root cause of pain has been treated or has healed. Pain that is severe that is unrelieved, however, might lead to persistent pain. Continual pain could have originated with disease or an initial trauma/injury, or there could be a continuous cause of pain. Nevertheless, some people suffer chronic pain in the lack of any past injury or evidence of body damage.

Before receiving treatment with the Senza System, patients participate in a one- to two-week simulation having an implanted trial lead along with a model of the stimulus generator that is worn outside the body. When the doctor discovers the stimulus works well based on the patient's reporting of symptoms, the system is implanted via a minimally invasive surgical procedure. The machine delivers electrical stimulation to the thoracolumbar area of the spinal cord (in the region of the middle to lower back) via leads implanted through a tiny incision in the patient's back. The lead is linked to your rechargeable, implantable pulse generator that is implanted in the patient's upper buttocks region or abdomen. A clinician software patients, and the apparatus can work with a remote to control the pulse generator inside the output ranges programmed by the clinician.

FDA's review of effectiveness and security contained data from a clinical study. Throughout the research, 198 subjects with chronic intractable pain of the torso and limbs were randomized to a control group or the Senza System evaluation group. The control group was made up of 97 topics treated with a different FDA-approved device that delivers stimulus in the two to 1,200 Hz frequency range that produced paresthesia.

Seventy-five percent of subjects treated with all the Senza System attained a 50 percent reduction in pain from baseline at three months, that was an approximately 55 percent decrease at 12 months, and the main objective of the analysis.

There have been no stimulus-associated neurological deficits, such as weakness in the limbs or tremors, observed for either treatment group. The most frequent adverse events related to the Senza System included pain beneath the skin in the implant site and dislocation of the apparatus lead.

The Senza System was also approved by the FDA for stimulus parameters For stimulation parameters, similar to those used in the control group as well as other conventional SCS systems, paresthesia is demanded.

Florida chronic pain treatment