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Non-pharmacological

Auricular vagus nerve stimulation modulates the body’s autonomic nervous system by electrical pulses, thus being highly effective and avoiding drug-related side effects.

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Sustainable

Auricular vagus nerve stimulation tackles the root cause of the disease, yielding a sustainable therapeutic effect rather than acting purely symptomatic.

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Easy to handle

Auricular vagus nerve stimulation is a minimally invasive therapy and can be administered easily by completing a few quick and simple working steps in an ambulatory environment.

Overview

Overview

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Disturbed Regulation

Many diseases manifest as a (chronic) dysregulation of the activating (sympathetic) and regenerative (parasympathetic) arms of the autonomic nervous system. This reflects in various symptoms such as chronic pain.

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Vagus Nerve

The Vagus Nerve holds a key role in the parasympathetic nervous system, controlling regenerative processes in the body. It is involved in the regulation of internal organs, the heart beat, the blood pressure, and the immune system.

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Personalized Stimulation

An electrical stimulation of sensory Vagus Nerve fibers via small needle electrodes in the auricle activates specific brainstem structures with a subsequent therapeutic effect. By personalized stimulation patterns, this effect can be optimized for each individual patient.

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Regeneration

Auricular Vagus Nerve Stimulation boosts parasympathetic activity, initiates regeneration, and reduces pain. By this, a sustainable therapeutic effect can be reached, without the side effects coming with pharmaceuticals.

The Vagus Nerve

The Vagus Nerve is the major constituent of the parasympathetic nervous system. Together with the sympathetic nervous system it plays an important role in continuously regulating vital body functions like heart rate, blood perfusion, and immune response. The Vagus Nerve slows down and regenerates the system.

As one of the twelve cranial nerves in the human body, the Vagus Nerve does not only transmit information from the brain to the organs, but also communicates the actual state of these organs to the brain. In fact, 80% of all fibers in the Vagus Nerve are such afferent / sensory fibers. This feedback is of major importance for the body’s homeostasis.

The Vagus Nerve supplies thoracic and abdominal cavities such as the esophagus, lower airways, heart, aorta, and the entire gastrointestinal tract (1). In addition, the Vagus Nerve sends afferent / sensory fibers to the external auditory channel and the auricle (2), which have been shown to project to the nucleus of the solitary tract in the brainstem (3).

The Vagus Nerve fibers in the concha of the auricle can be located easily by finding blood vessels wiring in parallel (4, 5). By the solely afferent / sensory innervation of the auricle, a direct influence on effector organs, and thus side effects, can be reduced.

The therapeutic action of auricular Vagus Nerve Stimulation in pain treatment is based on the masking of pain by the electrical stimulation pulses, the activation of inhibiting pain control systems, and the release of neurotransmitters, such as endorphins (6, 7). In parallel, an improved autonomic control can facilitate therapeutic effects and let them sustaine (1).

Sustainable therapeutic effects of Auricular Vagus Nerve Stimulation have already  been shown in several clinical studies.

Pain reduction, increased well-being, increased mobility, and increased sleep quality were observed in patients with chronic low back pain and cervical syndrome (6, 7).

Effectiveness of auricular Vagus Nerve Stimulation in chronic back pain patients could be confirmed also in a recent retrospective analysis (8).

Positive effects of auricular electrical stimulation on postoperative acute pain could be demonstrated in patients undergoing tonsillectomy and laparoscopic nephrectomy (9, 10).

In contrast to other therapeutic options, such as opioids or invasive spinal cord stimulation, auricular Vagus Nerve Stimulation provides a minimally invasive, non-pharmacological, and sustainable therapy for acute and chronic pain patients.

Pain Therapy

The VIVO System

VIVO is a CE marked innovative medical device for the electrical stimulation of sensory nerve fibers in the auricle. In particular, free nerve endings of the auricular branch of the Vagus Nerve are stimulated. The vagus nerve transmits the electrical signals to the brain and thus generates a therapeutic effect when suffering from pain, rather than being purely symptomatic as comparable stimulation therapies currently available. The auricular vagus nerve stimulation with VIVO offers you an aproved therapy for:

• Chronic Pain

• low back pain

• upper cervical syndrome

• migraine

• Acute Pain           

• post-operative pain

The battery-powered stimulation device VIVO is externally attached closely behind or underneath the ear. Three needle electrodes are placed in specific areas of the auricle in order to stimulate the auricular vagus nerve using an applicator. For localization of ideal application targets, the physician searches for vessel-nerve bundles in the vagally innervated region of the auricle. Only a few simple working steps are required for applying and activating VIVO.

After VIVO has been activated, it transmits electrical pulses to the nerves in the ear. A cyclic stimulation is applied with a fixed duty cycle and frequency for a period of 7-10 days (at common settings). The amplitude of stimulation and the therapy cycle can be adjusted individually to the patients needs.

VIVO uses triphasic burst stimulation, which has shown increased efficacy with respect to, e.g., single pulse biphasic stimulation (11). In a patient-centered design VIVO offers optimal usability, easy to apply and comfortable to wear.

For more detailed data on the application of VIVO, please refer to our brochure below or contact us directly.

VIVO is intended for the exclusive use by trained medical personnel. Prior to application, the instructions for use must be studied carefully.

References

(1) E. Kaniusas et al. Front Neurosci 13(854), 2019.
(2) E.T. Peuker and T.J. Filler. Clin Anat 15: 35-37, 2002.
(3) H.R. Berthoud and W.L. Neuhuber. Auton Neurosc Basic 85: 1-17, 2000.
(4) P. Carmeliet und M. Tessier-Lavigne. Nature 436(7048): 193-200, 2005.
(5) E. Kaniusas, G. Varoneckas, B. Mahr und J.C. Széles. IEEE Trans on Instr and Meas 60(10): 3253-3258, 2011.

(6) S.M. Sator-Katzenschlager, J.C. Széles, G. Scharbert et al. Anesth Analg 97(5):1496-73, 2003.
(7) S.M. Sator-Katzenschlager, G. Scharbert, S.A. Kozek-Langenecker et.al. Anesth Analg 98(5):1359-64, 2004.

(8) Széles et al. Annals in Pain Medicine 3(1):1009, 2021.
(9) Likar et al. Schmerz 21(2):154-9, 2007.
(10) Kager et al. Acute Pain 11(3):101-106, 2009
(11) E. Kaniusas et al. IEEE Trans Biomed Eng 67(7):1921-35, 2020.