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On May 8 2015, the U.S. Food and Drug Administration approved the Senza spinal cord stimulation (SCS) system (Senza System) as an assistance in the management of chronic intractable pain of the torso and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain. The Senza System can reduce pain without producing a tingling sensation called paresthesia by giving high frequency stimulation (at 10 KHz) and low stimulus amplitudes.

"The FDA has approved several other fully implanted spinal cord stimulators for pain decrease, but this system is unique since it delivers a high frequency output of 10 kHz that doesn't create a tingling sense--called 'paresthesia'--in patients," said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health. "Since some patients don't like the paresthesia associated with conventional SCS, this device offers another treatment alternative."

Back pain is a common disability for a lot of Americans. Intense pain starts suddenly and is usually sharp in quality. Intense pain could be light and last only a second, or it could be serious and may last three to six months. In most cases, acute pain disappears when the root cause of pain has been treated or has healed. Acute pain that is unrelieved, nevertheless, might cause chronic pain. Persistent pain is pain that lasts more than 12 weeks and might continue for many years. Chronic pain might have originated with disease or an initial trauma/injury, or there could be a continuing cause of pain. However, some individuals suffer chronic pain in the absence of any past injury or evidence of body damage.

Before receiving treatment with all the Senza System, patients participate in a one- to two-week simulation using an implanted trial lead and a model of the stimulus generator that is worn outside the body. Once the doctor determines the stimulation works well depending on the patient's reporting of symptoms, the system is implanted via a minimally invasive surgical procedure. The lead is linked into a rechargeable, implantable pulse generator which is implanted in the patient's upper buttocks area or abdomen. A clinician initially programs the apparatus, and patients can work with a remote to control the pulse generator inside the output ranges programmed by the clinician.

FDA's review of effectiveness and safety comprised data. Throughout the study, 198 subjects with chronic intractable pain of the trunk and/or limbs were randomized to a control group or the Senza System test group.

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

There were no stimulus-associated neurological deficits, such as weakness in the limbs or tremors, found for either treatment group. The most frequent adverse events linked to the Senza System included pain at the implant site and dislocation of the apparatus lead below skin.

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

Florida pain management