Medical devices that help patients regain functionality and sensation in paralyzed limbs landed a win with government approval of a key radio frequency tuned to transmitting signals through the body.
Medical Micropower Networks transmit radio signals among multiple microstimulators implanted in the body to activate and monitor nerves and muscles with electrical signals.
Early versions of the technology have allowed paraplegics to stand and the devices hold promise for patients with spinal cord injuries, traumatic brain injuries, strokes and other conditions by taking the place of damaged nerves.
"These broadband-enabled technologies are life-changing, impacting individuals, families, and communities in ways we can only begin to imagine," Federal Communications Commission chairman Julius Genachowski wrote in a prepared statement.
"This order is one of the most important the commission has adopted during my tenure, because the innovation it unleashes—medical micro power networks—has the potential to greatly improve the lives of those who are faced with some of today’s most difficult medical challenges," commissioner Mignon Clyburn wrote in his statement.
With the FCC’s green light to use the spectrum, the Alfred Mann Foundation plans to launch human trials and seek FDA clearance for MNN devices. AMF has yet to decide which products to push forward with first, CEO David Hankin told MassDevice, but the foundation has been making progress with upper limb paralysis treatments in collaboration with the Tampa, Fla., Dept. of Veteran Affairs that may be on the "short road" to FDA clearance.
Other treatments possibly on the horizon include a microstimulator system for treatment of dysphagia, a condition where patients have difficulty swallowing, Hankin said.
The AMF launched the initial petition in September 2007 to urge the FCC to open up the spectrum by demonstrating that medical devices wouldn’t disrupt other technologies communicating on those frequencies. The foundation has spent $115 million and 11 years developing microstimulator technology, according to Clyburn.
"The FCC’s decision removes the most significant roadblock to helping people. The frequency that has been approved for use is the most efficient for penetrating tissue with radio waves and without which the new generation of our implantable neurostimulator technology would be impossible to advance," Hankin said in prepared remarks. "The FCC worked hard and our scientists, engineers and prospective patients congratulate them for making a giant step toward making veterans’ and others’ lives better."
In a written response to the decision, FCC Commissioner Robert McDowell lauded the AMF for its perseverance and offered an apology on behalf of the government.
"Regrettably, bureaucratic delay literally forced disabled patients to wait much longer than necessary to benefit from some amazing emerging technologies," he wrote. "Congratulations to the paralyzed patients who now have more than hope to support them – they will have the power of their own bodies. To you I also offer the apology of your government for consuming nearly half a decade to reach this point."
The FCC granted the MMN systems a critical frequency band, between 413 megahertz and 457 megahertz, on which the transmitters may communicate. The same frequencies are used by the Dept. of Defense as well as amateur radio operators, Bloomberg reported.
Proving that medical devices on the frequencies wouldn’t interfere with or be disrupted by other technologies on the same channel, which the Dept. of Defense also uses, proved the bulk of the delay four year process, Hankin told us. But over the last year the process was frustrated by administrative delays.
All research and analysis had been filed by September 2010, but the process took another year to reach a decisive point.
