Stimwave wins FDA 510(k) for SCS device

Stimwave Technologies said it won FDA 510(k) clearance for its Stimwave Freedom-8A 8-electrode wireless neuromodulation spinal cord stimulation device for relieving chronic back and leg pain.

The Fort Lauderdale, Fla.-based company said it is the 1st wireless, fully programmable SCS neuromodulation device available. Stimwave said it has begun commercialization of the device and began implantation of the device in its 1st patients earlier this quarter.

Stimwave said it plans full nationwide commercialization of the device during early 2016.

“Patients utilizing the Stimwave Freedom-8A and Freedom-4A products not only have the option of a wireless device, but the recent advancements in this technology’s platform also provide the majority of the programming and placement features available from wired systems that are 95% larger. 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,” CEO Laura Perryman said in prepared remarks.

The Stimwave system is implanted in an outpatient procedure through a standard needle in a minimally invasive procedure, the company said. It sends small pulses of energy to trigger a reaction that causes allows the brain to remap specific pain signals to provide pain relief, Stimwave said.

“Patients’ needs in pain management are complex and unique. The Freedom-8A SCS System is a first-of-its-kind product and 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. This advancement will provide clinicians with a multitude of options and allow patients the most amount of freedom over their pain management,” Dr. David Kloth of the Connecticut Pain Care Center said in a prepared statement.

In June, the company won FDA investigational device exemption clearance to test an 8-electrode version of its wireless miniature neurostimulator device for the relief of chronic back and leg pain.

Miami, Fl.-based Stimwave said the FDA also approved a study of the device using high frequency treatments through an external pulse generator.

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