Masimo has introduced drug-free, non-surgical device Bridge to help with the reduction of symptoms associated with opioid withdrawal.
The new solution, which has been granted a Food and Drug Administration (FDA) De Novo classification, uses neuromodulation to reduce withdrawal symptoms.
Masimo’s solution includes a wearable, single-patient-use, percutaneous neurostimulator that can be placed behind the ear.
The device applies gentle electrical impulses to branches of the cranial nerves around the ear to reduce heightened neuron activity related to opioid withdrawal symptoms.
Opioid use, which also includes prescription opioids and heroin, kills many people in the US each year. Over 446,000 deaths were reported in relation to opioids from 1999 to 2018. 232,000 of these deaths were reportedly caused by the overdoses related to prescription opioids.
Painful and severe flu-like symptoms, which last up to two weeks, often accompanies opioid withdrawal. This makes voluntary discontinuation a challenging process for opioid users.
The fear of the physical and psychological effects of withdrawal acts as a barrier for patients with the opioid-use disorder (OUD), even in seeking treatment. Of the over two million people suffering from OUD in the US, less than 20% are said to be receiving the treatment.
By reducing withdrawal symptoms, Bridge helps patients with OUD to move from opioids into an appropriate treatment programme.
Masimo founder and CEO Joe Kiani said: “The opioid epidemic continues to impact millions of people around the world. Unassisted withdrawal from long-term use can be lengthy, extremely unpleasant, and there is a high risk of relapse.
“Effectively helping to reduce opioid withdrawal symptoms, which is what Bridge has been shown to do, is a critical first step toward successful illicit opioid cessation and treatment. This is the first tool that we are introducing to help with the opioid epidemic.”
The company noted that Bridge was found to reduce opioid withdrawal symptoms within 15-30 minutes in a clinical trial. It was also found to offer lasting relief for as long as it was applied, allowing opioids to leave the body.