Medical device firm Stimwave Technologies has obtained approval from the US Food and Drug Administration (FDA) for its eight-electrode wireless and micro-technology neuromodulation device to treat chronic back and leg pain.
The Stimwave Freedom-8A spinal cord stimulation (SCS) system is claimed to be the world’s first wireless and fully-programmable SCS neuromodulation device developed to provide relief from chronic back and leg pain.
The device allows clinicians to avoid the use of painful extensive tunneling and placement of internal batteries within the body.
It can be implanted in an outpatient procedure through a standard needle without using general anesthesia or a large surgical incision.
Stimwave Technologies chairman and CEO Laura Tyler Perryman said: "Patients utilizing the Stimwave Freedom-8A and Freedom-4A products not only have the option of a wireless device, but the recent advancements in this technology’s platform also provide the majority of the programming and placement features available from wired systems that are 95 percent larger.
"The safety and efficacy of even wider programmability options, or high-frequency programming up to 10,000Hz, is currently being investigated with an FDA approved clinical trial."
Last year, the Stimwave Freedom SCS system secured FDA approval for its four-electrode device, and was later upgraded to a fully-programmable model.
The Stimwave Freedom high frequency (HF) SCS system has not yet received approval for sale or commercial distribution, and is limited to investigational use only.
Image: The Stimwave Freedom-8A SCS system has obtained FDA approval to provide relief chronic back and leg pain. Photo: courtesy of artur84 / FreeDigitalPhotos.net.