STIVAX® pVNS PENS STIMULATOR
(Case of 12 Devices)
KEY FEATURES
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Minimally-invasive administration
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Significant reduction in treatment complexity
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Potential reduction in long-term treatment costs
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Easy application
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Protected from splashes
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Prescribed by a physician
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No active substances
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Enhancement of patient compliance
EACH DEVICE PACKAGE CONTAINS:
■ Water-resistant electronic stimulator
■ Multiple Swiss made titanium needle arrays
■ Adhesive backed clips for securing the stimulator to the patient
■ Array length estimators for approximating optimal shoulder placement
■ Several fixation plasters and alcohol swabs
■ Magnetic pin, used to change the output levels of the device
Devices come shipped in quantities of (3) devices in a 11x4x3 box, along with a 4th box with extra accessories.
DISCLAIMER: Providers should consult their own billing and reimbursement sources for appropriate billing codes and current rates applicable to them. It is our understanding that Medicare and some commercial insurance companies are not covering electro-acupuncture or auricular vagus nerve stimulation devices at this time.
Description
The device connects to the two tiny electrodes via a single lead wire. The physician will percutaneously implant the 38-gauge electrodes in the triangular fossa of the ear lobe, and affix them with surgical grade adhesive tape. The device will then be connected to the electrodes by the single lead wire, which will be affixed to a secure point on a location adjacent to the lower shoulder area.
This PENS stimulator device emits a low, imperceptible electrical current into the ear lobe, then on to the vagus nerve in the brain stem. This nerve affects the pain pathways in the spinal cord and reduces pain signals regardless of their cause.
The single Stivax package contains a single PENS device that is used throughout the entire 14-day treatment. Common packaging bundles 3 devices together with adjunctive components to cover a 60 day treatment period.
DISCLAIMER: Providers should consult their own billing and reimbursement sources for appropriate billing codes and current rates applicable to them. It is our understanding that Medicare and some commercial insurance companies are not covering electro-acupuncture or auricular vagus nerve stimulation devices at this time.
Additional information
Weight | 3 lbs |
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Dimensions | 12 × 6 × 6 in |
Documentation
Science Library
- E. Kaniusas, et al. Current Directions in the Auricular Vagus Nerve Stimulation I – A Physiological Perspective. Front Neurosci. 2019; 13: 854.
- Christopher R. Brown, et al., Peri‐Auricular Percutaneous Neurovascular Stimulation as a Non Narcotic Treatment Alternative for Acute and Chronic Pain. Clinical Medicine and Diagnostics 2015, 5(4): 70‐79. DOI: 10.5923/j.cmd.20150504.03
- Lerman, I, et al., Noninvasive vagus nerve stimulation alters neural response and physiological autonomic tone to noxious thermal challenge, PLOS 13‐FEB‐2019.
- Thomas Payritis, PhD. Clinical Study to Review the Effects of an Auricular and Percutaneous Electric Stimulation of Nervus Vagus on the Oxygen Supply of Skin of Patients with Severe Claudicatio Intermittens. Medizinische Statistik ASOKLIF. 15‐OCT‐2014.
- Hawkins JL, et al. Vagus nerve stimulation inhibits trigeminal nociception in a rodent model of episodic migraine. Pain Reports, 2017, Oct 17;2(6):e628. DOI: 10.1097/PR9.0000000000000628.
- Li S, et al. Auricular vagus nerve stimulation enhances central serotonergic function and inhibits diabetic neuropathy development in Zucker fatty rats. Mol Pain. 2018 Jan‐Dec;14: DOI: 10.1177/1744806918787368.
- Chou DE, et al. External Trigeminal Nerve Stimulation for the Acute Treatment of Migraine: Open‐Label Trial on Safety and Efficacy. Neuromodulation. 2017 Oct;20(7):678‐683. DOI: 10.1111/ner.12623.
- Lee PB, et al. Peripheral Nerve Stimulation for the Treatment of Chronic Intractable Headaches: Long‐term Efficacy and Safety Study. Pain Physician. 2015 Sep‐Oct;18(5):505‐16. PMID: 26431126.
- Richard L. Rauck, et al. Treatment of post‐amputation pain with peripheral nerve stimulation. Neuromodulation. 2014 Feb;17(2):188‐97. DOI 10.1111/ner.12102.
- Chakravarthy K, et al. Review of the Uses of Vagal Nerve Stimulation in Chronic Pain Management. Curr Pain Headache Rep. 2015 Dec;19(12):54. DOI: 10.1007/s11916‐015‐0528‐6.
- Yuan H, et al. Vagus Nerve Stimulation and Headache. Headache. 2017 Apr;57 Suppl 1:29‐33. DOI: 10.1111/head.12721. Epub 2015 Oct 16.
- Salman Hemani, Anna Woodbury, et al. (Emory Univ, VA Office of Research and Development). Feasibility Study: fMRI Evaluation of Auricular PENFS for Fibromyalgia (fMRI). 2019 Dec 3, ClinicalTrials.gov: NCT03008837.