dimecres, 23 de març del 2016

FDA clears Stimwave’s StimQ wireless chronic pain stimulator

StimwaveStimwave Technologies said today that it’s putting its StimQ peripheral nerve stimulator on the U.S. market after winning pre-market approval from the FDA earlier this month.

The StimQ device is designed to treat severe, intractable chronic pain in peripheral nerves, according to Ft. Lauderdale-based-based Stimwave. The tiny device, which is less than 5% of the size of standard implantable pain devices, can be implanted via a needle-sized cannula next the affected nerves, the company said.

StimQ is powered by the same wearable patch technology that powers the Freedom-8A spinal cord stimulator, which won an FDA nod in December 2015, Stimwave said.

“Thanks to our revolutionary wireless device, we are the only neuromodulation company cleared by the FDA to help patients with reducing their chronic neuropathic pain at most locations throughout the body. By providing an alternative to opioids, our Freedom SCS System helps minimize back and leg pain and now our new StimQ PNS system expands the treatment field by pinpointing stimulation directly to the affected peripheral nerves,” chairwoman & CEO Laura Tyler Perryman said in prepared remarks. “The StimQ PNS system can be placed directly at the site of pain at many peripheral nerve locations without wires and bulky battery implants, which opens up the ease and options for treatment.”

“The major issue with peripheral nerve stimulators in the past has always been the bulk and length of cables, connectors and pulse generators needed to stimulate a small target that is often ‘out on a limb,'” added Dr. Richard North, a consultant and retired neurosurgery professor at John Hopkins University School of Medicine. “A miniature wireless peripheral nerve stimulator will minimize the need for surgery in patients who already are suffering from pain. It has long been needed and now is finally a reality.”

The post FDA clears Stimwave’s StimQ wireless chronic pain stimulator appeared first on MassDevice.



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