A Vagus Nerve Stimulation(nVNS) device called gammaCore™, this week has received a Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for the treatment of posttraumatic stress disorder (PTSD) after showing a reduction of symptoms of PTSD by 31% when compared to sham treatment.
The Breakthrough Device Designation was supported, in part, by research from an Emory-Georgia Tech team led by J. Douglas Bremner, M.D., in the Departments of Psychiatry and Radiology at the Emory University School of Medicine, and Omer T. Inan, Ph.D., from the School of Electrical and Computer Engineering and the Coulter Department of Biomedical Engineering at the Georgia Institute of Technology in Atlanta, Georgia. Their research, built upon a strong mechanistic rationale and animal studies, shows nVNS blocks sympathetic and inflammatory responses to memories of traumatic events in patients with PTSD, modulates brain responses to traumatic memory, and reduces symptoms of PTSD by 31% when compared to a sham stimulation.
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to critical medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.
PTSD is a highly prevalent and disabling disorder with limited approved treatment options. According to the U.S. Department of Veterans Affairs National Center for PTSD, approximately 15 million adults in the U.S. experience PTSD each year. In the Military and Veterans Administration alone, PTSD is reported to affect between 10-20% of veterans who served in each Operations Iraqi Freedom (OIF) and Enduring Freedom (OEF), the Gulf War (Desert Storm), and the Vietnam War. More than half of all patients with PTSD report severely impaired quality of life in areas including mood, social and family relationships, leisure activities, sense of well-being and life satisfaction.
According to one of the investigators, Dr. Douglas Bremner commented, “Current treatments for PTSD involving medication and psychotherapy have limitations due to limited efficacy, possible side effects, and the unwillingness of many PTSD patients to engage in therapies that involve reliving traumatic memories. gammaCore represents a new class of treatment separate from medication or psychotherapy that is safe, relatively free of side effects, and does not involve costly and invasive procedures for implantation, like previous VNS devices approved by the FDA for treatment of refractory depression.”
Gammacore device has been previously approved by the FDA for: (Source: https://www.gammacore.com/)
Migraine – Clinically proven to treat and prevent migraines in users ages 12 and up. Help reduce migraines days without additional drugs.
Cluster Headache – The only clinically proven device to treat and prevent cluster headache attacks, while providing fast, reliable relief for those suffering with cluster headache.
Hemicrania Continua (HC) & Paroxysmal Hemicrania (PH) – 1st and ONLY device for HC and PH treatment, proven to reduce pain severity or headache frequency.
COVID-19 – Emergency Use Authorization to treat users with known or suspected COVID-19 and experiencing reduced airflow.