DyAnsys, a California-based medical machine firm specializing within the autonomic nervous system, introduced that Main Aid, its percutaneous electrical nerve stimulation (PENS) system, has acquired FDA approval to deal with postoperative ache after a coronary heart surgical procedure.
In line with DyAnsys, the PENS system can be utilized for as much as three days after coronary heart surgical procedure and, in a scientific trial, decreased ache scores in comparison with a placebo machine and the necessity for postoperative analgesics. The corporate additionally notes that fentanyl use by the first rescue group within the postoperative interval was one-third of the management group.
“This breakthrough machine supplies vital ache reduction with out using narcotics,” DyAnsys CEO Srini Nageshwar stated in an announcement. “By decreasing or avoiding using opioids after surgical procedure, the chance of habit is decreased.”
Main Aid has additionally acquired FDA clearance to be used in publish cesarean (caesarean) supply.
WHY IS IT IMPORTANT
Opioid use is a major drawback in america and overseas.
In 2019, earlier than the pandemic, a estimated at 10.1 million folks 12 years and older have abused opioids prior to now yr.
Practically 75% of drug overdose deaths in 2020 concerned an opioid, in line with the CDC.
Extra just lately in 2021there have been roughly 107,622 drug overdose deaths in america, a rise of practically 15% from the estimated 93,655 deaths in 2020.
THE GREAT TREND
Main Aid isn’t the primary machine developed by DyAnsys to focus on reducing opioid consumption by sufferers.
In June 2018, DyAnsys introduced that it had acquired FDA approval for Drug Aid, a wearable atrial neurostimulation machine designed to deal with opioid withdrawal signs.
In line with 510(ok) Utility, Drug Aid is a non-addictive therapy designed to help in detoxing. It’s worn on the pinnacle with needles inserted at three factors across the ear to facilitate electrical stimulation and is meant to be worn for 120 hours.
In line with DyAnsys, the wearer experiences a discount in drug withdrawal signs inside 30 to 60 minutes of beginning therapy.
Thus far, the FDA clearance for Main Aid is the fifteenth 510(ok) clearance DyAnsys has acquired.