California-based DyAnsys, a medical gadget firm specializing within the autonomous nervous system, has introduced that Main Aid, its percutaneous electrical nerve stimulator (PENS) system, acquired approval by the FDA to deal with postoperative ache following cardiac surgical procedure.
In keeping with DyAnsys, the PENS system can be utilized for as much as three days following cardiac surgical procedure and in a medical trial decreased ache scores in comparison with a placebo gadget –and lessened the necessity for analgesics postoperatively. The corporate additionally notes fentanyl use by the Main Aid group within the postoperative interval was one-third of the management group.
“This ground-breaking gadget permits for important ache aid with out using narcotics,” DyAnsys CEO Srini Nageshwar mentioned in an announcement. “By decreasing or avoiding using opioids after surgical procedure, the chance of dependancy is decreased.”
Main Aid has additionally acquired FDA clearance to be used in post-cesarean part (C-section) supply.
WHY IT MATTERS
Opioid use is a major downside within the U.S. and overseas.
In 2019, earlier than the pandemic, an estimated 10.1 million people 12 years and older misused opioids inside the previous yr.
Almost 75% of drug overdose deaths in 2020 concerned an opioid, in accordance with the CDC.
Extra just lately in 2021, there have been an estimated 107,622 drug overdose deaths within the U.S., a rise of practically 15% from the 93,655 deaths estimated in 2020.
THE LARGER TREND
Main Aid will not be the primary gadget DyAnsys developed to purpose at lowering sufferers’ use of opioids.
In June 2018, DyAnsys introduced it acquired FDA approval for Drug Aid, a wearable auricular neurostimulation gadget designed to deal with signs of opioid withdrawal.
In keeping with the 510(k) application, Drug Aid is a nonaddictive remedy designed to help with detoxing. It’s worn on the pinnacle, with needles inserted at three factors across the ear to facilitate electrical stimulation. It is meant to be worn for 120 hours.
Per DyAnsys, the wearer experiences a discount in drug-withdrawal signs inside 30 to 60 minutes of starting remedy.
Thus far, FDA clearance of Main Aid is the fifteenth 510(okay) clearance acquired by DyAnsys.
