The Food and Drug Administration (FDA) has cleared Primary Relief, a percutaneous electrical neurostimulation (PENS) device, for symptomatic relief of postoperative pain following caesarean section (C-section) delivery.
Primary Relief is a wearable, battery-operated device that delivers electrical pulses to branches of the cranial nerves on the ear through a wire assembly and stimulation needles. Once activated, the device administers periodic low level electrical pulses over 72 hours.
The approval was based on a single-center, double arm, randomized, controlled, parallel assignment prospective study that included 44 participants who underwent C-section delivery. Patients were randomly assigned into the intervention group who received the Primary Relief device as the primary method of analgesia and the control group who received standard analgesics for management of postoperative pain. The primary efficacy endpoint was pain intensity (measured using the Numerical Rating Scale over 72 hours).
Results showed that the reduction in pain score was faster with minimally invasive nerve stimulation using Primary Relief compared with standard analgesics. Findings also demonstrated that no additional opioid analgesics were required. As for safety, there were no complications or adverse events reported in the study.
“This device has been shown to make a difference for patients, effectively relieving pain without reliance on opioids or other analgesics,” said DyAnsys Chief Executive Srini Nageshwar. “We look forward to connecting with physicians and hospitals to providing this alternative to their patients.”
- FDA clears DyAnsys neurostimulation device primary relief to treat C-section pain. News release. DyAnsys, Inc. Accessed July 28, 2022. https://www.prnewswire.com/news-releases/fda-clears-dyansys-neurostimulation-device-primary-relief-to-treat-c-section-pain-301595255.html
- Primary Relief 510(k) summary. Food and Drug Administration. Accessed July 28, 2022. https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213188.pdf