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Calif.-based DyAnsys, a medical system firm specializing within the autonomous nervous system, introduced Major Aid, its percutaneous electrical nerve stimulator (PENS) system, obtained approval by the FDA to deal with postoperative ache following cardiac surgical procedure.
In line with DyAnsys, the PENS system can be utilized for as much as three days following cardiac surgical procedure and, in a scientific trial, lowered ache scores in comparison with a placebo system and the necessity for analgesics postoperatively. The corporate additionally notes fentanyl use by the Major Aid group within the postoperative interval was one-third of the management group.
“This ground-breaking system permits for important ache aid with out using narcotics,” DyAnsys CEO Srini Nageshwar stated in an announcement. “By lowering or avoiding using opioids after surgical procedure, the chance of dependancy is lowered.”
Major Aid has additionally obtained FDA clearance to be used in post-cesarean part (C-section) supply.
WHY IT MATTERS
Opioid use is a big drawback within the U.S. and overseas.
In 2019, earlier than the pandemic, an estimated 10.1 million people 12 years and older misused opioids throughout the previous 12 months.
Practically 75% of drug overdose deaths in 2020 concerned an opioid, in line with the CDC.
Extra not too long ago in 2021, there have been an estimated 107,622 drug overdose deaths within the U.S., a rise of almost 15% from the 93,655 deaths estimated in 2020.
THE LARGER TREND
Major Aid shouldn’t be the primary system DyAnsys developed to focus on reducing sufferers’ use of opioids.
In June 2018, DyAnsys introduced it obtained FDA approval for Drug Aid, a wearable auricular neurostimulation system designed to deal with signs of opioid withdrawal.
In line with the 510(k) application, Drug Aid is a non-addictive remedy designed to help with cleansing. It’s worn on one’s head with needles inserted at three factors across the ear to facilitate electrical stimulation and 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.
To this point, FDA clearance of Major Aid is the fifteenth 510(okay) clearance obtained by DyAnsys.
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