Posted : Tuesday Dec 6, 2011 16:51:29 EST
The Federal Communications Commission’s approval of the Alfred Mann Foundation’s medical technology, which uses implanted devices connected to a wireless network to reanimate limbs, sets the stage for further testing and possible approval by the Food and Drug Administration for expanded use.
The technology, called the Medical Micropower Network, has the potential to improve the lives of military veterans with traumatic brain injuries, spinal cord injuries or severe injuries to the limbs, as well as to people who have suffered strokes, multiple sclerosis and cerebral palsy.
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David Hankin, CEO of the nonprofit Mann foundation, said FCC approval was possible only because of cooperation by the Defense Department, who conducted interference tests because the devices access part of the radio spectrum used by the military. The DoD’s tests found the low-powered devices that activate nerves and muscles did interfere with military use of the radio spectrum, but that interference was manageable, Hankin said. In extreme cases, the wireless network linking the microprocessors could shut down if in the vicinity of high-power devices, but it is also possible to change channels or stage a “graceful” shutdown so that a person using the device would not face harm, he said.
“There was no question there is going to be some interference,” he said. The tests, however, showed the problem is “non-harmful,” he said.
FCC’s decision applies not just to this prototype, but to the concept of extremely low-powered medical devices. In a statement, the FCC said the micropowered devices “can provide effective therapy for debilitating conditions by taking the place of damaged nerves to restore sensation, mobility and other functions to limbs and other parts of the body.”
Approval “will allow devices such as those being tested by Alfred Mann to proceed on the path to patient use, as well as inspire researchers to begin work on the next generation of implanted medical radio networks.”
The reanimation technology developed by the foundation would be an option to similar wired systems that exist today.
There are several benefits to having wireless systems, Hankin said. The surgery to implant medical devices is far less invasive because no wires are required. The wireless system could be inserted in a doctor’s office rather than an operating room, he said. Additionally, wired systems have problems with infection and with wires fraying at joints, which requires surgery to remove the wires and devices.
Hanks said the next step is to get FDA approval for human clinical trials, which could take one to three years. He expects some of those trials to involve veterans.