FDA clears primary relief of DyAnsys neurostimulation device to treat cesarean section pain

PALO ALTO, Calif., July 28, 2022 /PRNewswire/ — DyAnsys, Inc., announced that Primary Relief, a percutaneous electrical nerve stimulation device, has been cleared to treat pain after cesarean section (C-section).

Demonstration of testing for placement of Primary Relief, a percutaneous electrical nerve stimulation device licensed for the treatment of pain following cesarean section (C-section). The device is manufactured and distributed by DyAnsys Inc.

Primary Relief, a PENS device, is a meaningful alternative to opioids for the treatment of pain after cesarean section.

The Percutaneous Electrical Nerve Stimulation System (PENS) can be used for up to three days for symptomatic relief of postoperative pain following cesarean delivery.

“This device has been shown to make a difference for patients, providing effective pain relief without the need for opioids or other painkillers. This is a significant step forward in providing options for women,” said the CEO of DyAnsys. Srini Nageshwar. “We look forward to connecting with doctors and hospitals to bring this alternative to their patients.”

The portable, battery-operated device is designed to deliver periodic low-level electrical pulses to the ear for 72 hours from device activation. The electrical impulses are delivered to the branches of the cranial nerves of the ear by an assembly of wires and stimulation needles.

The effectiveness of the device has been demonstrated in a prospective single-center, dual-arm, randomized, controlled, parallel-assignment study involving 44 participants who underwent cesarean delivery. The analysis showed that a minimally invasive nerve stimulation intervention using a primary relief device reduced pain score faster than standard painkillers. No additional opioid analgesics were required. No complications or adverse events were observed in any of the participants during the study period.

Non-clinical testing of the Primary Relief device included biocompatibility testing, electrical safety (electromagnetic compatibility and safety), bench performance testing, and software verification and validation.

DyAnsys offers two companion PENS devices – First Relief, with FDA clearance for the treatment of diabetic neuropathic pain, and Drug Relief, with FDA clearance as a drug withdrawal aid.

DyAnsys Inc. is a global company headquartered in California with subsidiaries in Swiss and India. DyAnsys provides advanced medical diagnostic and monitoring systems to clinicians in individual practices and hospitals. DyAnsys, ANSiscope. First Relief, Primary Relief and Drug Relief are registered trademarks of DyAnsys, Inc.

Website: www.dyansys.com

for more information contact Srini Nageshwar(888) 950-4321



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