Stimwave Receives FDA 510(k) Clearance for the First Full-Body MRI Scan Ready Wireless Peripheral Nerve Stimulator (PNS) System

POMPANO BEACH, Fla.--(BUSINESS WIRE)--Stimwave LLC, a leading innovator in wireless medical device technology and independent research institute, has received FDA 510(k) clearance for the first wireless, micro-technology neuromodulation device that can enable ongoing full-body MRI scans under certain scanning conditions for the relief of chronic peripheral nerve pain.

Representing a life-changing technological breakthrough for the more than 400 million people worldwide who suffer from severe intractable chronic pain, the StimQ Peripheral Nerve Stimulator (PNS) System offers an alternative for those who do not want to rely on invasive surgical procedures or ongoing opioid treatments. The smallest neuromodulation device available, the StimQ device can be placed in a minimally-invasive, outpatient procedure for the treatment of various pain syndromes, including, but not limited to: shoulder pain, upper extremity neuropathy, mid and lower back pain, and lower extremity neuropathy. The new FDA clearance enables the pain sufferer to have frequent and necessary MRI scans of any part of their body without removing the implant.

“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,” said Stimwave Chairman and CEO Laura Tyler Perryman.

“This is great news for many chronic pain patients who previously did not have a minimally-invasive implant option available for peripheral nerve-related pain and will continue to require frequent MRI scans throughout their body for management of their pain and monitoring of their current and future medical needs,” said Dr. Konstantin Slavin, professor of neurosurgery at University of Illinois at Chicago and author of the book “Peripheral Nerve Stimulation.” “While PNS has been shown in literature to be an effective treatment, for many years device placement has been difficult due to the bulk and length of cables, connectors and pulse generators needed to stimulate a small nerve target. This miniature wireless peripheral nerve stimulator that minimizes the need for surgery in patients who are already suffering from pain, while allowing on-going care with full body MRI scan capabilities may provide a viable, non-opioid option for long-term pain management.”

The state-of-the-art device, which is less than five percent of the size of other standard implanted options, provides pain relief by delivering small pulses of energy in a fully-selectable manner to electrodes placed at a peripheral nerve enabling the brain to remap specific pain signals. The implant is powered by a small, flexible and comfortable wearable external unit. The company previously received FDA clearance for the Freedom-8A/4A Spinal Cord Stimulation (SCS) System, which is also full body MRI scan cleared and utilizes the same technology specifically for back and leg pain based on placements in the spinal column region. Both the Freedom SCS System and the StimQ PNS System are available now, and more information can be found at www.stimwave.com.

About Stimwave LLC

Stimwave LLC is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management.