Stimwave’s PNS device secures FDA 510(k) clearance
Medical device technology firm Stimwave has received a 510(k) clearance from the US Food and Drug Administration (FDA) for its StimQ Peripheral Nerve Stimulator (PNS) System.
StimQ is a small, wireless, micro-technology neuromodulation device developed to offer an alternative to opioids or invasive surgical procedures for patients with chronic pain.
The PNS system is designed to allow ongoing full-body MRI scans under select scanning conditions for the chronic peripheral nerve pain relief.
It can be implanted using a minimally invasive outpatient procedure to treat a variety of pain syndromes such as shoulder pain, upper extremity neuropathy, mid and lower back pain, and lower extremity neuropathy.
Stimwave chairman and CEO Laura Tyler Perryman said: “Thanks to our revolutionary wireless device, we are the only neuromodulation company cleared by the FDA to help patients reduce their chronic neuropathic pain by pinpointing stimulation directly to the affected peripheral nerves with a multi-electrode programmable device, which enables ongoing MRI scans.”
Following the FDA clearance, patients implanted with the device will be eligible to undergo frequent and necessary MRI scans of any body part without the need for removal of the implant.
The StimQ PNS System delivers small pulses of energy in a fully selectable approach to electrodes placed at a peripheral nerve to provide relief by allowing the brain to remap certain pain signals.
Powered by a small, comfortable, flexible wearable external unit, the device is said to be less than 5% of the size of other existing standard implanted options.