Injectable Wireless Device for Back, Leg Pain Approved by FDA

Stimwave Technologies Inc. has received U.S. Food and Drug Administration (FDA) clearance to market a wireless, micro-technology neuromodulation device for chronic back and leg pain. Currently being marketed throughout Europe, Stimwave’s revolutionary electroceutical device will be commercially available in the United States next month.

Representing a technological breakthrough for the more than 400 million people worldwide who endure daily chronic pain, the Stimwave Freedom Spinal Cord Stimulation (SCS) System is the smallest neuromodulation device available, according to the Miami, Fla.-based company.

The technology, developed by scientists and engineers led by co-inventor and 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 is different about Stimwave is the small size of the device – between two 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), Stimwave bigwigs noted. More than 80 percent of the complications in neuromodulation therapy result from large, bulky devices and associated connections. With Stimwave’s 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.

The Stimwave electroceutical device contains no internal batteries or other toxic materials and is 95 percent smaller than the smallest available implantable battery, the company claims. 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 Dr. David Kloth, M.D., medical director of the Connecticut Pain Care Center.

Stimwave Technologies is a privately held medical device company that develops, manufactures and commercializes wirelessly powered, injectable, microtechnology neurostimulators.