Stimwave Spinal Cord Stimulation Device Gets FDA OK

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An “electroceutical” device that relieves chronic back and leg pain has received marketing approval from the U.S. FDA.

The Stimwave Freedom Spinal Cord Stimulation system, which is already on the market in Europe and will be available in the U.S. in January, is an injectable microchip neuromodulation device that sends small electric pulses to electrodes near surrounding nerves, causing the brain to reroute certain pain signals. Notably, the device may help curb dependency on narcotic analgesics.

Previous neuromodulation devices have been larger in size and needed to be connected to a power source via wires, often resulting in complications. However, the Stimwave is between two and 11 centimeters long, is wireless, and can be implanted using a standard needle.

The company also noted that the device, which is meant for permanent, long-term use, contains no batteries or toxic materials and does not need to be removed while a patient undergoes a 3T or 1.5T whole-body MRI, setting it further apart from other devices. 

Stimwave Technologies
Stimwave Spinal Cord Stimulation Device Gets FDA OK

The US Food and Drug Administration (FDA) has granted marketing clearance for an injectable microchip neuromodulation device for the relief of chronic back and leg pain.

The Stimwave Freedom Spinal Cord Stimulation (SCS) system is expected to be available in the United States as of January 2015, the company, Stimwave Technologies Inc, reported in a statement released December 2.

The device, which the company calls an "electroceutical" device, is already marketed throughout Europe for this indication. 

Developed by scientists and engineers led by co-inventor and company chairman Laura Tyler Perryman, the technology involves a tiny injectable microchip device that delivers small energy pulses to electrodes near surrounding nerves, the statement notes.

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