California-based DyAnsys, a medical device company specializing in autonomic nervous systems, has announced Primary Relief, a percutaneous electrical nerve stimulator (PENS) machine system, which has received approval from FDA for the treatment of postoperative pain following cardiac surgery.
According to DyAnsys, the PENS system can be used for up to three days after heart surgery and, in one clinical trial, reduced pain scores compared to a placebo device and the need for analgesia after surgery. The company also noted that the primary Relief group’s use of fentanyl in the postoperative period was one-third that of the control group.
“This groundbreaking device enables significant pain relief without the use of drugs,” DyAnsys CEO Srini Nageshwar said in a statement. “By reducing or avoiding opioid use after surgery, the risk of addiction is reduced.”
Primary Relief has also received FDA approval for use in a cesarean section after a cesarean section (cesarean section).
WHY IT IMPORTANT
Opioid use is a serious problem in the US and abroad.
In 2019, before the pandemic, a estimated 10.1 million people 12 years or older abused opioids in the past year.
Nearly 75% of drug overdose deaths in 2020 involve opioids, according to CDC.
More recently in 2021There have been an estimated 107,622 drug overdose deaths in the US, up nearly 15% from the 93,655 estimated deaths in 2020.
TREND TO BIGGER WOMAN
Primary Relief is not the first device DyAnsys has developed to target patients who are reducing their opioid use.
In June 2018, DyAnsys announced it had received FDA approval for Drug Relief, a wearable intraventricular nerve stimulator designed to treat opioid withdrawal symptoms.
Follow Application 510(k), Drug Relief is a non-addictive treatment designed to aid in withdrawal. It is worn on the head with needles inserted at three points around the ear to facilitate electrical stimulation and is intended to be worn for 120 hours.
According to DyAnsys, wearers experience relief from drug withdrawal symptoms within 30 to 60 minutes of starting treatment.
To date, the FDA certification for Mitigation is the 15th 510(k) certification DyAnsys has received.
