Manufacturer Announces FDA Clearance for US Marketing of Neuromodulation Device

A Miami-based medical device manufacturer has received FDA clearance to begin US marketing of the first wireless, microtechnology neuromodulation device for relief of chronic back and leg pain. Currently being marketed throughout Europe, the device from Stimwave Technologies, Inc., will be commercially available in the US as of January 2015. According to the manufacturer, the new injectable device contains no internal batteries or toxic materials and is the smallest neuromodulation device available.

Neuromodulation has been a proven FDA-approved treatment for back and leg pain for more than 30 years, but the size and bulk of currently available technologies, and the associated connections required, are responsible for over 80% of the complications resulting from neuromodulation therapy. With the Stimwave technology, only a small device with electrode contacts and an embedded chip is placed within the body through a needle, significantly reducing the time required for the minimally-invasive outpatient procedure, and providing a lower cost option for pain therapy.

A press release from the manufacturer discussing the new technology may be read here.

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