Electroceutical Device Eases Chronic Back and Leg Pain

A new injectable neuromodulation device powered by an externally worn transmitter aids in the relief of chronic back and leg pain.

The Stimwave Freedom Spinal Cord Stimulation (SCS) system is based on a tiny injectable microchip that delivers small pulses of energy to electrodes near surrounding nerves, triggering a reaction that enables the brain to remap specific pain signals, thus providing pain relief. The stimulator, which is so narrow (1.3 mm) that it can be implanted through a standard needle, eliminates the need for long electrical leads necessary in pacemaker-like devices. Containing 4 electrode arrays, the stimulator is fixed in place by a suture sleeve cap anchor, serving as a permanent, long-term device.

The SCS is powered by a wearable antenna assembly (WAA) that uses wireless radiofrequency (RF) signals; wireless Bluetooth technology is also used to program the WAA with specific stimulation parameters. For added safety, the neurostimulator only accepts communication from a specific WAA. The system also features the ability to allow the patient to have a whole body 3 T or 1.5 T magnetic resonance imaging (MRI) scan, without removing the implant. The Stimwave Freedom SCS system is a product of Stimwave Technologies (Miami Beach, FL, USA), and has been approved by the US Food and Drug Administration (FDA).

“This technology is no longer an academic-type science experiment, but a real, viable innovation that can immediately start being utilized by patients in pain,” said Laura Tyler Perryman, MSc, MBA, co-inventor of the SCS system and CEO and chairman of Stimwave Technologies. “Historically with SCS, dependency on pain medications can be drastically reduced or even eliminated.”

“I am extremely excited about this new technology developed by Stimwave and recent clearance by the FDA,” said David Kloth, MD, medical director of the Connecticut Pain Care Center and author of the book Pain Wise. “Now people in pain will have additional options including the ability to receive a permanent implant with a far less invasive and complicated surgery, while avoiding the cumbersome long-term issues with recharging, as is the case today with other systems.”

SCS, in the simplest form, consists of stimulating electrodes implanted in the epidural space. It has notable analgesic properties and, at the present, is used mostly in the treatment of failed back surgery syndrome, complex regional pain syndrome, and refractory pain due to ischemia.

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