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| Stimwave's Freedom Spinal Cord Stimulation (SCS) System--Courtesy of StimWave |
Chronic back pain is notoriously difficult to treat with existing surgical or therapeutic options. Now physicians can add another tool to their arsenal that targets the pain locally, without requiring surgery or an external device. The FDA has cleared Stimwave Technologies' Freedom Spinal Cord Stimulation (SCS) System, which the company says is the smallest available neuromodulation device.
The device is "the world's smallest, wireless, injectable neurostimulator," according to Stimwave, and it relies upon recent advances in nanotechnology. It's already marketed in Europe and expected to be commercially available in the U.S. in January.
The FDA cleared the device for relief of chronic back and leg pain. It includes an injectable microchip and electrodes that deliver small electrical pulses to the surrounding nerves that cause the brain to remap pain signals, thereby providing pain relief.
"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," Stimwave chairman and CEO Laura Tyler Perryman said in a statement.
The device is only 0.25 centimeters long and can fit through a standard-gauge needle for placement without surgery. It is fixed in place with an anchor, so it's not expected to move within the body. It is intended to be a permanent, long-term implant.
Also, the system is designed to allow an MRI without the removal of the implant, which the company said is a unique feature. The SCS system doesn't require batteries, making it easier to achieve the minuscule size.
"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, Medical Director of the Connecticut Pain Care Center, said in a statement.
The Miami Beach, FL-based Stimwave came out of the Arizona life sciences incubator BioAccel.
- here is the release