FDA clears Stimwave’s injectable wireless pain relief system

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Stimwave has received FDA clearance to market its wireless microtechnology neuromodulation device for relief of chronic back and leg pain. Currently being marketed throughout Europe, Stimwave’s electroceutical device will be commercially available in the USA as of January 2015.

Stimwave says that the Stimwave Freedom spinal cord stimulation system is the smallest neuromodulation device available. The technology, developed by scientists and engineers led by co-inventor and chairman Laura Tyler Perryman, uses an injectable microchip device 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. Historically with spinal cord stimulation system, dependency on pain medications can be drastically reduced or even eliminated. “This technology is no longer an academic-type science experiment, but a real, viable innovation that can immediately start being utilised by patients in pain,” says Perryman.

Stimwave believes that its device is an industry first due to its small size – from 2cm–11cm, so small that it can be implanted through a standard needle – as well due to the elimination of the long wires tunnelled through the body and connected to the battery source. Over 80% of the complications in neuromodulation therapy result from these devices and associated connections. With the Stimwave technology, only a small device with electrode contacts and an embedded chip is placed within the body through a needle, shortening the time required significantly for the minimally-invasive, outpatient procedure, and enabling a lower cost option for the industry.

The Stimwave electroceutical device contains no internal batteries or other toxic materials and is 95% smaller than the smallest available implantable battery. The Stimwave device is fixed in place by an anchor, so it does not move except with body movement. It naturally stays “in line” with the body’s nerves, allowing a freedom of motion not possible with bulkier implanted devices. The Stimwave device is a permanent, long-term implant. The system features the ability to allow the patient to have a whole body 3T or 1.5T MRI, without removing the implant.

“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,” says David Kloth, medical director of the Connecticut Pain Care Center and author of Pain Wise.

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