The US Food and Drug Administration (FDA) has granted marketing clearance for an injectable microchip neuromodulation device for the relief of chronic back and leg pain.
The Stimwave Freedom Spinal Cord Stimulation (SCS) system is expected to be available in the United States as of January 2015, the company, Stimwave Technologies Inc, reported in a statement released December 2.
The device, which the company calls an "electroceutical" device, is already marketed throughout Europe for this indication.
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 notes. 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 said in the statement.
Neuromodulation has been an FDA-approved treatment for back and leg pain for more than 30 years, but the difference for this new device is the small size, the release adds. Measuring between 2 and 11 cm, it can be implanted through a standard needle, making implantation a shorter and less expensive procedure. It is also wireless, eliminating the need for wires to be connected to a power source. These external wires are the root of more than 80% of complications associated with neuromodulation therapy, the company said.
Further, the device contains 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 notes. "It naturally stays 'in line' with the body's nerves allowing a freedom of motion that is impossible with bulkier implanted devices," it says.
Patients can also undergo whole-body 3T or 1.5T MRI without removing the device, "which is unique in the industry," the company adds.
More information can be found at www.stimwave.com.
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Cite this: FDA Okays Injectable Stimulation Device for Back, Leg Pain - Medscape - Dec 03, 2014.