Device Name: ST Genesis
Manufacturer: Speranza Therapeutics
FDA Approved: May 2, 2018
S.T. Genesis is a Percutaneous Nerve Field Stimulator (PNFS) that supports reduction of opioid withdrawal symptoms through application to branches of cranial nerves V, VII, IX, and X as well as the occipital nerves
OVERVIEW OF DISEASE STATE
Disease State: Opioid use disorder (OUD) is the condition in which an individual continues persistent use of opioids despite the harmful consequences of its use. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), defines OUD as “a problematic pattern of opioid use leading to clinically significant impairment or distress.”
Diagnosis: The diagnosis of OUD is made using the International Classification of Diseases 11th revision or Diagnostic and Statistical Manual of Mental Disorders 5th edition criteria (DSM-5). Clinicians also evaluate the OUD severity using the DSM-5; presence of 2–3 criteria is considered mild, 4–5 moderate, and 6 or more is severe on the OUD spectrum.
Treatment: There are effective psychosocial and pharmacological interventions for opioid use disorders. Psychosocial therapies such as cognitive behavioral therapies, relapse prevention, contingency management and motivational enhancement therapy can be used by themselves or in combination with a pharmacotherapy. Pharmacotherapy options include opioid agonists, partial agonists and antagonists, as well as alpha-2-adrenergic agonists, which are used to manage symptoms of opioid withdrawal syndrome.
Medication-assisted treatment (MAT) is the use of medications with counseling and behavioral therapies to treat opioid use disorders and prevent overdose. Conventional MAT includes the medications methadone, buprenorphine, Naloxone and Naltrexone, and Lofexidine (Lucemyra).
Opioid Withdrawal is an obstacle to treatment among individuals with OUD. Abrupt cessation of opioids after repeated use leads to opioid withdrawal symptoms, which are frequently severe, and may prompt patients to restart opioids in the early days after opioid discontinuation or prevent them from attempting to stop discontinue use of opioids at all. These symptoms can also lead to opioid seeking in pain patients in whom acute opioid withdrawal is not effectively managed.
The ST Genesis is changing how we treat OUD Patients. No more horrible side effects from using Opioids as a part of the recovery process. Improve patient OUD outcomes and while lowering clinical costs.