California-based DyAnsys, a medical device company specializing in the autonomous nervous system, has announced that Primary Relief, its percutaneous electrical nerve stimulator (PENS) system, received approval by the FDA to treat postoperative pain following cardiac surgery.
According to DyAnsys, the PENS system can be used for up to three days following cardiac surgery and in a clinical trial reduced pain scores compared to a placebo device –and lessened the need for analgesics postoperatively. The company also notes fentanyl use by the Primary Relief group in the postoperative period was one-third of the control group.
“This ground-breaking device allows for significant pain relief without the use of narcotics,” DyAnsys CEO Srini Nageshwar said in a statement. “By reducing or avoiding the use of opioids after surgery, the risk of addiction is reduced.”
Primary Relief has also received FDA clearance for use in post-cesarean section (C-section) delivery.
WHY IT MATTERS
Opioid use is a significant problem in the U.S. and abroad.
In 2019, before the pandemic, an estimated 10.1 million people 12 years and older misused opioids within the past year.
Nearly 75% of drug overdose deaths in 2020 involved an opioid, according to the CDC.
More recently in 2021, there were an estimated 107,622 drug overdose deaths in the U.S., an increase of nearly 15% from the 93,655 deaths estimated in 2020.
THE LARGER TREND
Primary Relief is not the first device DyAnsys developed to aim at decreasing patients’ use of opioids.
In June 2018, DyAnsys announced it received FDA approval for Drug Relief, a wearable auricular neurostimulation device designed to treat symptoms of opioid withdrawal.
According to the 510(k) application, Drug Relief is a nonaddictive treatment designed to assist with detoxification. It is worn on the head, with needles inserted at three points around the ear to facilitate electrical stimulation. It’s meant to be worn for 120 hours.
Per DyAnsys, the wearer experiences a reduction in drug-withdrawal symptoms within 30 to 60 minutes of beginning treatment.
To date, FDA clearance of Primary Relief is the 15th 510(k) clearance received by DyAnsys.