FDA permits marketing of the first device to help ease opioid withdrawal

Amid an epidemic of opioid addiction, doctors are looking for ways to assist individuals to wean themselves off of the medicine, but withdrawal symptoms are a serious hurdle. Innovative Health Solutions says its NSS-2 Bridge is a “percutaneous nerve field stimulator (PNFS) device system” that sends electrical pulses to certain cranial nerves, treating symptoms together with sweating, tremors, sweating, stomach upset, joint pain and anxiety. Yesterday the FDA cleared it for marketing, making this the 1st device approved to be used in this method.

Like the DEKA Arm System, this device was reviewed through the agency’s de novo pathway that fast-tracks “some low- to moderate-risk devices.” prior to approval, the Food and Drug Administration reviewed a clinical study of seventy-three patients where all of them showed at least a 31 % drop in their clinical opiate withdrawal scale (COWS) score within 30 minutes of use.