Stimwave’s MRI-safe, injectable neurostimulator gets FDA nod

With the new FDA clearance, patients implanted with Stimwave's peripheral neurostimulator may undergo full-body MRI without needing to remove the device.

Stimwave scored FDA clearance for its tiny, MRI-safe neurostimulation device for the treatment of chronic peripheral nerve pain. Now, patients implanted with the device may undergo full-body MRI scans without needing to remove the implant.

The StimQ Peripheral Nerve Stimulator system is placed through a needle and is designed to stimulate any peripheral nerve below the head and outside the spinal cord.

The wireless device is designed to treat chronic pain, including shoulder pain, mid- and lower back pain and neuropathy in the upper and lower extremities. It delivers small electrical pulses through a set of electrodes to the targeted nerve. It is powered by a small external unit.

"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, a professor of neurosurgery at University of Illinois at Chicago, in the statement.

RELATED: Startup gains FDA clearance for first tiny, injectable neuromodulation system for back pain

Stimwave also markets the Freedom Spinal Cord Stimulation (SCS) system, which is placed near the spinal cord to relieve chronic low back and leg pain.

Neurostimulation is an alternative treatment to opioids and invasive surgery for patients with chronic pain. MRI-compatibility makes such devices an option for patients with chronic pain who were previously ineligible because they might need diagnostic imaging in the future.

Last November, St. Jude Medical—now a division of Abbott—snagged a full-body MRI label from the FDA for its Elite Spinal Cord Stimulation System. The device, which does not need to be recharged, is indicated for the treatment of chronic back pain.