FDA Clears Wireless Neuromodulation Device for Chronic Leg and Back Pain

Stimwave Technologies Inc., a medical device manufacturer and independent research institute headquartered in Miami Beach, Fla., received U.S. Food and Drug Administration (FDA) clearance to market what the company claims is the world’s first wireless, microtechnology neuromodulation device for relief of chronic back and leg pain. Company officials also say the Stimwave Freedom spinal cord stimulation (SCS) system is the smallest neuromodulation device available.

Currently being marketed throughout Europe, Stimwave’s device will be commercially available in the United States as of January 2015.

The technology, developed by scientists and engineers led by co-inventor and company chairman Laura Tyler Perryman, uses a tiny 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 SCS, 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 utilized by patients in pain,” said Perryman.

While neuromodulation has been a proven, FDA-approved treatment for back and leg pain for more than 30 years, what’s different about Stimwave is the small size of the device—between 2 and 11 centimeters, so small that it can be implanted through a standard needle—as well as the elimination of the long wires having to be painfully tunneled through the body and connected to the battery source (a pacemaker-like device). More than 80 percent of the complications in neuromodulation therapy result from such large, bulky devices and associated connections, Stimwave officials say.

With the Stimwave technology, a small device with electrode contacts and an embedded chip is placed within the body through a needle, shortening the time required for the minimally invasive, outpatient procedure, in addition to the additional intended benefit of reducing cost.

The Stimwave electroceutical device contains no internal batteries or other toxic materials and is 95 percent smaller than the smallest available implantable battery. The Stimwave device is fixed in place by an anchor, so it doesn’t move except with the body movement. It naturally stays “in line” with the body’s nerves, allowing a freedom of motion that is impossible 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.

“I am extremely excited about this new technology developed by Stimwave and recent clearance by the FDA. 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,” said David Kloth, M.D., medical director of the Connecticut Pain Care Center and author of “Pain Wise,” a guide to pain management.

Stimwave Technologies is a privately held and focused on wirelessly powered, injectable, microtechnology neurostimulators.