USA – The US Food and Drug Administration (FDA) has cleared Primary Relief, a percutaneous electrical neurostimulation (PENS) device developed by DyAnsys, to treat postoperative pain following caesarean section (C-section) delivery.

The percutaneous electrical nerve stimulator (PENS) system can be used for up to three days for symptomatic relief of post-operative pain following a C-section delivery.

Primary Relief, a PENS device, is a significant alternative to opioids for the treatment of pain following a C-section.

Opioids are a class of drugs that include the prescription pain relievers oxycodone, hydrocodone, morphine, methadone, and fentanyl, as well as the illegal drug heroin.

The rate of opioid misuse and overdoses is at an all-time high, and research has previously found that more than 1 in 300 women who are given opioids for the first time after a cesarean delivery become persistent users of the drugs.

A study by UT Southwestern obstetrician-gynecologists, published in the American Journal of Obstetrics & Gynecology, shows how one approach, which primarily uses non-opioid drugs, successfully managed women’s pain while boosting breastfeeding rates and decreasing the use of opioids by more than 75%.

Primary Relief, a PENS device, is a significant alternative to opioids for the treatment of pain following a C-section.

Another study’s results published in the Turk J Phys Med Rehabil. Journal suggest that TENS is an effective and safe non-invasive, non-pharmacological treatment modality, and is thus preferred as an alternative method in pain control in postpartum women after C-section delivery.

DyAnsys Chief Executive Srini Nageshwar said: “This device has been shown to make a difference for patients, effectively relieving pain without reliance on opioids or other analgesics. This is a significant advancement in providing options to women.”

“We look forward to connecting with physicians and hospitals to providing this alternative to their patients.”

With the approval, DyAnsysc can plug into the global neurostimulation devices market valued to clock US$14 billion by 2030.

The market is expected to grow at a CAGR of 13% during the forecast period (2022–2030), according Yahoo Finance.

The wearable, battery-operated device is designed to administer periodic low-level electrical pulses to the ear over 72 hours from the activation of the device.

The electrical pulses are delivered to branches of the cranial nerves on the ear through a wire assembly and stimulation needles.

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.

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