FDA Clears World’s First Fully Programmable, Implantable Peripheral Nerve Stimulator

Stimwave, LLC, a leading innovator in wireless medical device technology and independent research institute, today announced that it has begun to market the StimQ Peripheral Nerve Stimulator (PNS) System for the relief of severe intractable chronic pain of peripheral origin. The system can provide relief to peripheral nerves with a implantable device that can be optionally placed through a needle-sized cannula to next to peripheral nerve locations where the pain is originating. The StimQ PNS System, the world’s first wireless, fully programmable PNS (peripheral nerve stimulator) neuromodulation device, received FDA 510k clearance this month. It presents a potentially life-changing technological breakthrough for the 400 million people worldwide who suffer from severe intractable chronic pain that do not want to rely on invasive surgical procedures or ongoing opioid (narcotic) treatment for pain management.
 
“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,” said Stimwave Chairman and CEO Laura Tyler Perryman. “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 wireless implantable device’s form factor represents a major breakthrough in the field of neuromodulation and eliminates the need for painful, extensive tunneling and placement of internal batteries within the body. The StimQ PNS System can be implanted through a standard needle size insert or small incision. This is in contrast to current products on the market, which require general anesthesia and a large surgical incision with tunneling wires throughout the body and across joints to reach a remote battery unit also requiring surgery. This wireless neuromodulation approach is expected to significantly reduce the lifetime cost of care for chronic pain patients and offer a safe, viable and effective alternative to pain medications.
 
“This is great news for pain specialists and chronic pain patients who previously did not have a minimally-invasive implant option available for peripheral nerve related pain. The StimQ PNS product line provides an alternative for pain control besides medications,” said Dr. Sanjay Gupta, president of the American Pain Association and principal clinician at Atlantic Pain and Wellness Institute. “Our country is facing a horrible epidemic of drug overdose deaths, which has led the American Pain Association to launch an awareness campaign. These wireless products provide an alternative to opioids, which is much needed in the armamentarium for effective pain control.”
 
This new indication will allow the use of wirelessly powered, micro-technology neurostimulators to be used for the treatment of various pain syndromes including, but not limited to: shoulder, upper extremity neuropathies, mid and low back pain, chest wall pain, abdominal wall pain, hernia pain, pelvic pain, as well as lower extremity neuropathies at the knee, tibial, ankle, and foot.
 
“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,’” said Richard North, MD, consultant and retired Professor of Neurosurgery 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 technology leverages a miniature, state-of-the-art device—which is less than 5 percent of the size of other standard implanted options—that delivers small pulses of energy, in a fully-selectable manner, to electrodes placed at a peripheral nerve. The implant is powered by a small, flexible and comfortable wearable external fabric patch unit. The company previously received FDA clearance for the Freedom-8A/4A Spinal Cord Stimulation (SCS) System, which utilizes the same technology specifically for back and leg pain based on placements only in the spinal column region for the device.