By Susan Jeffrey
Medscape Medical News
Dec. 4, 2014 -- The FDA has approved an injectable microchip nerve-stimulation device for the relief of ongoing back and leg pain.
The Stimwave Freedom Spinal Cord Stimulation (SCS) system is expected to be available in the United States next January, the company, Stimwave Technologies Inc., said in a statement.
The device is already being sold in Europe to treat back and leg pain.
Developed by scientists and engineers led by co-inventor and company chairman Laura Tyler Perryman, the technology involves a tiny injectable microchip device that delivers small energy pulses to electrodes near surrounding nerves, the statement says. It "trigger[s] 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," Perryman says in the statement.
Neuromodulation, or nerve stimulation, has been an FDA-approved treatment for back and leg pain for more than 30 years. The difference for this new device is the small size, the release says. Measuring between 2 cm and 11 cm, it can be implanted through a standard needle, making that process shorter and less expensive.
It is also wireless, getting rid of the need for wires to be connected to a power source. These external wires are the root of more than 80% of complications linked to this type of therapy, the company says.
The device has no internal batteries or other toxic materials, and is fixed in place by an anchor to limit its movement. It is a "permanent, long-term implant," the release says. "It naturally stays 'in line' with the body's nerves, allowing a freedom of motion that is impossible with bulkier implanted devices.”
People can also get a whole-body MRI scan without removing the device, "which is unique in the industry," the company says.
source : FDA Approves Injectable Device for Back, Leg Pain
