DyAnsys’ neurostimulation system receives FDA clearance to deal with post-cardiac surgical procedure ache

Calif.-based DyAnsys, a medical system firm specializing within the autonomous nervous system, introduced Main Aid, its percutaneous electrical nerve stimulator (PENS) system, acquired approval by the FDA to deal with postoperative ache following cardiac surgical procedure.  

In accordance 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 system and 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 system permits for vital ache reduction with out using narcotics,” DyAnsys CEO Srini Nageshwar stated in a press release. “By lowering or avoiding using opioids after surgical procedure, the chance of habit 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 big drawback within the U.S. and overseas. 

In 2019, earlier than the pandemic, an estimated 10.1 million individuals 12 years and older misused opioids throughout the previous yr.

Practically 75% of drug overdose deaths in 2020 concerned an opioid, in line with the CDC. 

Extra 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 shouldn’t be the primary system DyAnsys developed to focus on lowering sufferers’ use of opioids. 

In June 2018, DyAnsys introduced it acquired FDA approval for Drug Aid, a wearable auricular neurostimulation system designed to deal with signs of opioid withdrawal.

In accordance with the 510(ok) utility, Drug Aid is a non-addictive therapy 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 therapy. 

Up to now, FDA clearance of Main Aid is the fifteenth 510(ok) clearance acquired by DyAnsys.