Read this section to gather important prescription and safety information. J Neurol Surg Rep. 2016;77:e67–e72. On December 9, 2015, Stimwave Technologies Inc. announced FDA clearance of its Stimwave Freedom-8A SCS system. The agency granted clearance to a four-electrode device last year made by the same company. The trial lasts up to 10 days. A wireless device (Stimwave) is devoid of IPG costs and required a 3-year maintenance costs of 1500 Euros only. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. On December 9, 2015, Stimwave Technologies Inc. announced FDA clearance of its Stimwave Freedom-8A SCS system. Read this section to gather important prescription and safety information. (4) Wireless spinal cord stimulation has been used effectively for the treatment of pain syndromes of multiple etiologies (5). Wireless High Frequency Spinal Cord Stimulation for Chronic Pain . Spinal Cord Stimulation Prescription and Safety Information . The system is intended to be used with leads and associated extensions that are compatible with the system. Pain Medication Reduction. BACKGROUND: "Traditional" spinal cord stimulation (SCS) trials with percutaneous electrodes externalized to a pulse generator (PG) are typically limited in duration due to risk of infection. The FDA has granted clearance to the world's smallest wireless eight-electrode spinal cord stimulator (SCS) system. Spinal Cord Stimulation (SCS) SCS, also known as nerve stimulation, or neurostimulation, uses electrical signals to interrupt the perception of pain traveling from the painful area to the brain. Prospective, Randomized, Multi-Center Non-Inferiority Study to Assess . Methods. The agency granted clearance to a four-electrode device last year made by the same company. Listing a study does not mean it has been evaluated by the U.S. Federal Government. BACKGROUND: This study aimed to evaluate the wireless Freedom Spinal Cord Stimulator (WSCS) System for the treatment of chronic back and/or leg pain associated with failed back surgery syndrome (FBSS) refractory to standard medical treatment utilizing 10-kHz stimulation (high-frequency [HF]) in comparison with 10-1,500-Hz stimulation (low-frequency [LF]) waveforms. This study aimed to evaluate the wireless Freedom Spinal Cord Stimulator (WSCS) System for the treat-ment of chronic back and/or leg pain associated with failed back surgery syndrome (FBSS) refractory to standard medical treatment utilizing 10-kHz stimulation (high-frequency [HF]) in comparison with 10–1,500-Hz stimulation (low-frequency [LF]) waveforms. … Mild electrical pulses from the external neurostimulator (A) travel through the temporary leads (B) to the nerves near your spinal cord. analgesia and function. Spinal Cord Stimulator System Information for Prescribers 91171759-02 Content: 92191001 REV A CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician. Rapid technological changes in spinal cord stimulation and peripheral nerve field stimulation are extending the therapy’s potential benefits to a wider range of people. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. J Neurol Surg Rep. 2016;77:e67–e72.