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The FDA Approves Spinal Cord Stimulation System Which Treats Pain Without Tingling Sensation
The Senza System can reduce pain without producing a tingling sensation called paresthesia by giving high frequency stimulus (at 10 KHz) and low stimulation amplitudes.

"The FDA has approved several other totally implanted spinal cord stimulators for pain reduction, yet this system is unique as it provides a high frequency output signal of 10 kHz that doesn't cause a tingling sense--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 option."

Back pain is a typical impairment for several Americans. Extreme pain is usually sharp in quality and begins suddenly. Intense pain could be light and last only a minute, or it might be intense and may last. In most cases, intense pain vanishes when the root source of pain was treated or has cured. Unrelieved severe pain, however, might cause chronic pain. Continual pain might have originated with an initial trauma/injury or illness, or there could be an ongoing cause of pain.

Before receiving treatment with all the Senza System, patients take part in a one- to two-week simulation having an implanted trial lead as well as a model of the stimulus generator that is worn outside the body. Once the physician determines the stimulus functions nicely according to 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 planted through a little incision in the patient's back. The lead is connected to a rechargeable, implantable pulse generator which is implanted in abdomen or the patient's upper buttocks area. A clinician initially applications the device, and patients can utilize a remote to control the pulse generator inside the output signal ranges programmed by the clinician.

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

Seventy-five percent of subjects treated together with the Senza System achieved a 50 percent decrease in pain from baseline at three months, that has been an about 55 percent reduction at 12 months, and the main goal of the analysis.

There have been no stimulation-associated neurological deficits, including weakness in the limbs or tremors, observed for either treatment group. The most common adverse events linked to the Senza System comprised pain beneath the skin in the implant site and dislocation of the device lead.

The FDA also approved the Senza System for stimulus parameters below 10 KHz. For stimulus parameters, similar to those used in the control group as well as other traditional SCS systems, paresthesia is necessary.

Florida chronic pain treatment





 
 
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