FDA clears Stimwave’s miniature StimQ peripheral nerve stimulator

Stimwave Freedom-4 stimulator
Stimwave Freedom-4 stimulator

Stimwave has begun to market the StimQ peripheral nerve stimulator (PNS) system for the relief of severe intractable chronic pain of peripheral origin.

The system is designed to provide relief to peripheral nerves with an 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, also received US Food and Drug Administration (FDA) 510k clearance this month.

“By providing an alternative to opioids, our Freedom spinal cord stimulation (SCS) system helps minimise back and leg pain, and now our new StimQ PNS System expands the treatment field by pinpointing stimulation directly to the affected peripheral nerves,” says Stimwave chairman and chief executive officer, 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.”

The StimQ PNS System can be implanted through a standard needle size insert or small incision. According to a company release, 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.

Sanjay Gupta, president of the American Pain Association and principal clinician at Atlantic Pain and Wellness Institute, says “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,’” says Richard North, consultant and retired professor of Neurosurgery at John Hopkins University School of Medicine, Baltimore, USA. “A miniature wireless peripheral nerve stimulator will minimise 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 uses a miniature device—which is less than 5% 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 utilises the same technology specifically for back and leg pain based on placements only in the spinal column region for the device.