Stimwave Freedom-8A spinal cord stimulation system receives FDA clearance


The Stimwave Freedom-8A spinal cord stimulation (SCS) system has been granted FDA clearance to be marketed for the relief of chronic back and leg pain. This system comprises an eight-electrode wireless, micro-technology neuromodulation device for the relief of chronic back and leg pain.

Stimwave has also started commercialisation of the product. Implantation began in the first patients earlier this quarter, and full commercialisation within the US is due to start at the beginning of January 2016.

“The recent advancements in this technology’s platform provide the majority of the programming and placement features available from wired systems that are 95% larger,” says Stimwave Chairman and CEO, Laura Tyler Perryman. “The safety and efficacy of even wider programmability options, or high-frequency programming up to 10,000 Hz, is currently being investigated with an FDA approved clinical trial.”

The wireless device is designed to eliminates the need for painful extensive tunnelling and placement of internal batteries within the body. The Freedom-8A stimulator is implanted in an outpatient procedure through a standard needle with no need for general anaesthesia or a large surgical incision. The company expects that the approach will reduce the lifetime cost of care for chronic pain patients and offer a safe, viable and effective alternative to pain medications, according to a press release.

“The Freedom-8A SCS System 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,” says David Kloth, medical director of the Connecticut Pain Care Centre and author of Pain Wise.

According to a press release, the technology leverages a tiny device that delivers small pulses of energy, in a fully-selectable manner, to eight electrodes placed near surrounding nerves, triggering a reaction that enables the brain to remap specific pain signals, thus providing pain relief. The Stimwave Freedom Spinal Cord SCS system received FDA clearance for its four-electrode device last year, which has also been upgraded to a fully-programmable model.