Fort Lauderdale-based company Stimwave Technologies announced today that its eight-electrode wireless, micro-technology neuromodulation device for relief of chronic back and leg pain received FDA 510(k) clearance. The Company plans to begin full nationwide commercialization January 1, 2016.
According to Stimwave, its Freedom-8A Spinal Cord Stimulation (SCS) System is the world’s first fully-programmable wireless SCS neuromodulation device that eliminates the need for painful tunneling and internal battery placement within the body. Stimwave states that its device features a compact 0.4 cc profile and eight electrodes placed near nerve fibers around the dorsal aspect of the spinal column. The device is said to deliver selected pulses of energy to the electrodes to alter the transmission of pain signals to the brain. Additionally, Stimwave notes that its device is implanted in an outpatient setting through a standard needle, eliminating the need for general anesthesia or a large surgical incision.
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“Patients’ needs in pain management are complex and unique. The Freedom-8A SCS System is a first-of-its-kind product and offers a wide variety of advanced programming features, polarity selection options for up to eight separate electrodes per device, in the body in the least invasive fashion ever offered. This advancement will provide clinicians with a multitude of options and allow patients the most amount of freedom over their pain management.”
According to the press release, Stimwave is currently investigating the safety and efficacy of even wider programmability options, such as high-frequency programming up to 10,000 Hz, in an FDA approved clinical trial.