FDA clears Innovative Health Solutions opioid withdrawal treating neuromod

Innovative Health Solutions won FDA clearance for a new indication for its NSS-2 Bridge device, now cleared to reduce symptoms of opioid withdrawal, according to an FDA release. The NSS-2 Bridge device is a small electrical nerve stimulator designed to be placed behind a patient’s ear and emit electrical pulses to stimulate branches of certain cranial nerves, which may provide relief from opioid withdrawal symptoms. Clearance came based of a single-arm clinical study of 73 patients undergoing opioid physical withdrawal symptoms, with researchers evaluating clinical opiate withdrawal scale scores. Prior to using the device, patients had an average reported COWS score of 20.1. After treatment, all patients showed a COWS score reduction of at least 31% within 30 minutes of using the device. A total 88% of patients transitioned to medication assisted therapy after 5 days of using the device, according to the FDA press release. “Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment. There are three approved drugs for helping treat opioid addiction. While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy. The FDA is committed to supporting the development of novel treatments, both drugs and devices, that can be used to address opioid de...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance innovativehealthsolutions Source Type: news

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Publication date: May–June 2018Source: EXPLORE, Volume 14, Issue 3Author(s): Heather Tick, Arya Nielsen, Kenneth R. Pelletier, Robert Bonakdar, Samantha Simmons, Ronald Glick, Emily Ratner, Russell L. Lemmon, Peter Wayne, Veronica Zador, The Pain Task Force of the Academic Consortium for Integrative Medicine and HealthABSTRACTMedical pain management is in crisis; from the pervasiveness of pain to inadequate pain treatment, from the escalation of prescription opioids to an epidemic in addiction, diversion and overdose deaths. The rising costs of pain care and managing adverse effects of that care have prompted action ...
Source: EXPLORE: The Journal of Science and Healing - Category: Complementary Medicine Source Type: research
Publication date: Available online 1 March 2018 Source:EXPLORE Author(s): Heather Tick, Arya Nielsen, Kenneth R. Pelletier, Robert Bonakdar, Samantha Simmons, Ronald Glick, Emily Ratner, Russell L. Lemmon, Peter Wayne, Veronica Zador Consortium Pain Taskforce White Paper Summary Evidence-based Nonpharmacologic Strategies for Comprehensive Pain Care Supplementary information can be found in the online version at https://doi.org/10.1016/j.explore.2018.02.001. Medical pain management is in crisis; from the pervasiveness of pain to inadequate pain treatment, from the escalation of prescription opioids to an epidemic in addict...
Source: EXPLORE: The Journal of Science and Healing - Category: Complementary Medicine Source Type: research
Publication date: Available online 1 March 2018 Source:EXPLORE Author(s): Heather Tick, Arya Nielsen, Kenneth R. Pelletier, Robert Bonakdar, Samantha Simmons, Ronald Glick, Emily Ratner, Russell L. Lemmon, Peter Wayne, Veronica Zador Medical pain management is in crisis: from the pervasiveness of pain to inadequate pain treatment, from the escalation of prescription opioids to an epidemic in addiction, diversion and overdose deaths. The rising costs of pain care and managing adverse effects of that care has prompted action from state and federal agencies including the DOD, VHA, NIH, FDA and CDC. There is pressure for pain...
Source: EXPLORE: The Journal of Science and Healing - Category: Complementary Medicine Source Type: research
I never wanted to be a drug pusher. A career in medicine was the opposite — healing in place of harming. However, I knew something was wrong when a detective asked to speak to me about one of my patients. My patient, addicted to Vicodin, had committed several acts of fraud and theft in desperate attempt to satisfy her needs. Her arrest was the final step in a long, slow unraveling of a happy and productive life. I was not just a witness to this painful process; I was an active participant. As her primary care physician, I helped fuel her addiction and shared in the responsibility. When the history of the opiate epide...
Source: Kevin, M.D. - Medical Weblog - Category: General Medicine Authors: Tags: Physician Pain Management Primary Care Source Type: blogs
The Food and Drug Administration (FDA) hasapproved the use of an electric stimulation device to help to reduce the symptoms of opioid withdrawal, marking the first time a device has been indicated for withdrawal symptoms.The NSS-2 Bridge is a small device placed behind the patient ’s ear that emits electrical pulses to stimulate cranial nerves. These stimulations provide relief from common withdrawal symptoms during the first few days of drug abstinence; these include sweating, tremors, stomach problems, insomnia, and joint pain.“Given the scope of the epidemic of opioid addiction, we need to find innovative ne...
Source: Psychiatr News - Category: Psychiatry Tags: electric stimulator FDA medication-assisted treatment NSS-2 Bridge opioid use disorder opioid withdrawal Source Type: research
It will take more than medication alone to win the battle against opioid addiction, and now U.S. clinicians finally have a device-based therapy to help reduce the symptoms of opioid withdrawal. FDA granted a new indication to Innovative Health Solutions for its NSS-2 Bridge nerve stimulator. The new indication was reviewed under FDA's de novo pathway. “There are three approved drugs for helping treat opioid addiction. While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy,” said FDA Commissioner Scott Gottlieb, MD. G...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news
Publication date: November 2017 Source:Journal of Integrative Medicine, Volume 15, Issue 6 Author(s): Arthur Yin Fan, David W. Miller, Bonnie Bolash, Matthew Bauer, John McDonald, Sarah Faggert, Hongjian He, Yong Ming Li, Amy Matecki, Lindy Camardella, Mel Hopper Koppelman, Jennifer A.M. Stone, Lindsay Meade, John Pang The United States (U.S.) is facing a national opioid epidemic, and medical systems are in need of non-pharmacologic strategies that can be employed to decrease the public's opioid dependence. Acupuncture has emerged as a powerful, evidence-based, safe, cost-effective, and available treatment modality suitab...
Source: Journal of Integrative Medicine - Category: Complementary Medicine Source Type: research
On September 8, 1854, acting on the advice of Dr. John Snow, London municipal authorities removed the pump handle from the Broad Street well in an effort to halt a major outbreak of cholera. Although an anesthesiologist by profession, Snow had methodically mapped the homes of new cases of cholera. He found that many clustered around the Broad Street pump. Snow’s findings, still regarded as a classic example of epidemiology, established the principle: “that the most important information to have about any communicable disease is its mode of communication.” Dr. Snow did not establish the biologic mechanism ...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: Featured Public Health Quality Department of Veterans Affairs military health care Opioid Addiction opioid epidemic Source Type: blogs
The federal government has declared, through its major health policy agencies, that the number of pain patients on opioids and the dosages they are on should be severely restricted.  The Center for Disease Control (CDC), Veteran’s Administration (VA) and Centers for Medicare and Medicaid Services (CMS) have all issued new guidelines within the past year to that effect.  Private insurers are following suit, in many cases refusing to pay for high dose opioids. More recently, the American College of Physicians issued new guidelines for the treatment of low back pain that recommend using nonpharmacological ther...
Source: Kevin, M.D. - Medical Weblog - Category: Journals (General) Authors: Tags: Meds Pain management Source Type: blogs
With so many political crises to attend to daily, it’s hard not to let important issues fall by the wayside. However, with the unveiling of the Republican plan to reform the Affordable Care Act (ACA) and the powerful opposition to that plan, nothing is being done to address the opioid abuse epidemic our nation faces. Every day we turn our attention to other matters, Americans die of overdose. But there is something we can do while the national debate on health insurance rages – encourage the use of medical marijuana for pain sufferers. More than half the states in the nation and the District of Columbia have l...
Source: Cliffside Malibu - Category: Addiction Authors: Tags: Richard Taite Source Type: blogs
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