Primary Relief is a wearable, battery-operated percutaneous electrical nerve stimulator (PENS) system designed to constantly deliver low-level electrical pulses to the ear, for up to 72 hours after the device is activated
Primary Relief percutaneous neurostimulation device. (Credit: PRNewswire/DyAnsys Inc.)
US-based medical equipment manufacturer DyAnsys has received the US Food and Drug Administration (FDA) approval for its neurostimulation device Primary Relief.
Primary Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for the treatment of postoperative pain after cardiac surgery.
It is a wearable, battery-operated device designed to constantly deliver low-level electrical pulses to the ear, for up to 72 hours after its activation.
Primary Relief delivers the electrical pulses to branches of the cranial nerves on the ear through a wire assembly and stimulation needles.
Last month, DyAnsys secured the US FDA approval for Primary Relief to treat pain following Cesarean section (C-section) delivery.
The device serves as an alternative to opioids for the treatment of pain following a C-section.
DyAnsys chief executive Srini Nageshwar said: “This ground-breaking device allows for significant pain relief without the use of narcotics.
“By reducing or avoiding the use of opioids after surgery, the risk of addiction is reduced. We look forward to connecting with physicians and patients to make this option available after cardiac surgery among other applications.”
DyAnsys evaluated the effectiveness of Primary Relief in a single-centre, double-arm, randomised study for the treatment of post-cardiac surgery in 60 patients.
In the study analysis, the participants receiving minimally invasive nerve stimulation from Primary Relief experienced a superior pain reduction compared to placebo.
The device also reduced the need for post-surgery analgesics, where the mean dosage of fentanyl as a postoperative rescue analgesic was only one-third of the control group.
Furthermore, Primary Relief was tested for biocompatibility, electromagnetic compatibility and safety, performance bench testing and software verification and validation.
With subsidiaries in Switzerland and India, DyAnsys provides advanced medical diagnostic and monitoring systems to clinicians.
The company also offers two other FDA-approved companion PENS devices, First Relief to treat diabetic neuropathic pain, and Drug Relief to aid drug withdrawal.