Senza SCS System (Senza System) is an implanted, rechargeable spinal cord stimulation system for the treatment of chronic pain of the trunk and/or limbs that is difficult to manage (intractable). The main components include an implanted signal generator that is connected to one or two implanted leads, and external doctor and patient controllers.
How does it work? The doctor implants the signal generator and leads through a small incision in the patient’s back. The implanted signal generator receives radio signals from the doctor or patient controller. The controller tells the signal generator when and how to deliver appropriate electrical stimulation to the spinal cord through the implanted leads. The device can deliver high frequency stimulation (10 kHz) which, in combination with low stimulation amplitudes, cannot be felt by the patient. It can also be programmed to deliver low frequency stimulation that can be felt as a tingling sensation by the patient, similar to other devices currently on the market.
When is it used? The Senza System is used as an aid in the management of chronic intractable pain of the trunk and/or limbs. This includes one-sided or two- sided pain associated with failed back surgery syndrome, intractable low back pain, and leg pain.
What will it accomplish? The Senza System may help treat chronic pain in the trunk and/or limbs that is difficult to manage.
When should it not be used?
- In patients who have not received effective pain relief during a trial stimulation or are poor surgical risks.
- With shortwave, microwave and/or therapeutic ultrasound diathermy.
Patients with the Senza System can only be exposed to MRI using special procedures outlined in the device labeling. The energy generated during MRI and diathermy can be transferred through the Senza System, causing tissue damage at the lead site that may result in severe injury or death.
