Masimo, a medical technology company, announced Bridge, an opioid withdrawal solution. The drug-free device applies electrical impulses to the cranial nerves around the ear, which can reduce neuron activity and opioid withdrawal symptoms. Bridge has been granted an FDA De Novo classification. It the first evidence-based, drug-free, non-surgical device of its kind.
Opioid withdrawal is often accompanied by painful, often severe flu-like symptoms lasting for up to two weeks, making voluntary discontinuation by opioid users a long, challenging process. For many patients with opioid use disorder (OUD), fear of the physical and psychological effects of withdrawal can be a barrier to even attempting to seek treatment. It has been estimated that less than 20% of the more than two million people suffering from OUD in the United States are receiving treatment, reports BusinessWire.
In clinical testing, Bridge was found to reduce opioid withdrawal symptoms within 15-30 minutes and provide continuous relief for as long as it was applied, which can be up to 120 hours per device, allowing opioids to leave the body. In a study of 73 adult OUD patients, it was shown that withdrawal symptoms (such as increases in resting pulse rate, sweating, restlessness, bone or joint aches, tremors, and anxiety) were reduced by 85% after the first hour of using the device and 97% after 5 days of use (measured using the clinical opiate withdrawal scale).
The solution consists of a wearable, single-patient-use, percutaneous neurostimulator, fitted behind the ear, which applies gentle electrical impulses to branches of the cranial nerves around the ear. These electrical impulses to the cranial nerves have been found to reduce heightened neuron activity, which is associated with opioid withdrawal symptoms. Bridge can be easily applied by a healthcare professional in a simple, non-surgical, in-office procedure, and its use doesn’t interfere with normal daily activities such as work or school.
Joe Kiani, Founder and CEO of Masimo, 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. We are committed to doing what we can to help reduce opioid-related deaths.”
Read more This Wearable Detects Opioid Overdose and Automatically Calls for Help
From 1999 to 2018, opioids were involved in more than 446,000 deaths in the United States. Of these cases approximately 232,000 were the result of overdoses related to prescription opioids. In 2018, the most recent year for which data is available, approximately 47,000 deaths involved opioids, almost 15,000 of which involved prescription opioids.
