{
  "abstract": "Background and Objectives Stimulation of the Vagus Nerve is a clinically proven treatment option for epilepsy, stroke rehabilitation, chronic or recurrent depression as adjunctive therapy, and rheumatoid arthritis, all commercially available as FDA approved systems. It is also being researched for heart failure, and relapsing-remitting multiple sclerosis among other disease states. These are chronic therapies wherein electrodes are implanted directly on the Vagus nerve in the form of cuffs or an implantable, integrated neurostimulator, requiring an invasive cervical cutdown procedure. This makes it impossible to revise the position of the nerve cuff without additional surgery. Also, currently the feedback from the nerve upon stimulation delivery is not monitored.Methods In this work, we propose the development of chronically implantable endovascular VNS system that helps mitigate the challenges highlighted earlier and demonstrate this in a pre-clinical model on four subjects for long term use (~120 days). In this minimally invasive procedure, an electrode array disposed on a re-sheathable stent form factor is deployed within the jugular vein providing an opportunity for intra-procedural trialing. VNS is delivered to the subjects weekly during awake monitoring sessions. Post term, detailed histopathological evaluation is conducted to study effects of stim on the vessel and nerve. Furthermore, findings related to thrombosis, and endothelialisation are also studied.Results We demonstrate repeatable activation of the Vagus Nerve (VN) via Evoked Compound Action Potential (ECAP) sensing during anesthetized intra-procedural trialing and subsequently during awake monitoring sessions over ~120 days in all 4 subjects consistently. The system is capable of tuning stimulation using the closed loop feature for patient specific therapy. Furthermore, the system maintains complete functionality during chronic implantation and stable performance with endothelialisation of the stent. We observed low activation potentials throughout the chronic period, no signs of vessel or nerve damage from stimulation or stenting, and no signs of thrombosis from long term implantation.Conclusion This chronic endovascular VNS system provides a minimally invasive platform technology for several peripheral nerve stimulation therapies requiring long term implantation.Disclosures V. Kashyap: 4; C; Medtronic. 5; C; Medtronic. Z. Sanger: 4; C; Medtronic. 5; C; Medtronic. M. Ashby: 4; C; Medtronic. 5; C; Medtronic. S. Stanslaski: 4; C; Medtronic. 5; C; Medtronic. K. Nguyen: 4; C; Medtronic. 5; C; Medtronic. A. Nageswaran: 4; C; Medtronic. 5; C; Medtronic. R. Olson: 4; C; Medtronic. 5; C; Medtronic. D. Seeley: 4; C; Medtronic. 5; C; Medtronic. H. Huna: 4; C; Medtronic. 5; C; Medtronic. A. Shi: 4; C; Medtronic. 5; C; Medtronic. E. Fahimi: 4; C; Medtronic. 5; C; Medtronic. P. Falkner: 4; C; Medtronic. 5; C; Medtronic. A. Khalessi: 2; C; Medtronic.",
  "authors": [
    {
      "affiliations": [
        "Neurovascular, Medtronic, Irvine, CA"
      ],
      "name": "V Kashyap"
    },
    {
      "affiliations": [
        "Neuromodulation, Medtronic, Fridley, MN"
      ],
      "name": "Z Sanger"
    },
    {
      "affiliations": [
        "Neurovascular, Medtronic, Irvine, CA"
      ],
      "name": "M Ashby"
    },
    {
      "affiliations": [
        "Neuromodulation, Medtronic, Fridley, MN"
      ],
      "name": "S Stanslaski"
    },
    {
      "affiliations": [
        "Neurovascular, Medtronic, Irvine, CA"
      ],
      "name": "K Nguyen"
    },
    {
      "affiliations": [
        "Neurovascular, Medtronic, Irvine, CA"
      ],
      "name": "A Nageswaran"
    },
    {
      "affiliations": [
        "Neuromodulation, Medtronic, Fridley, MN"
      ],
      "name": "R Olson"
    },
    {
      "affiliations": [
        "Neuromodulation, Medtronic, Fridley, MN"
      ],
      "name": "D Seeley"
    },
    {
      "affiliations": [
        "Neuromodulation, Medtronic, Fridley, MN"
      ],
      "name": "H Huna"
    },
    {
      "affiliations": [
        "Neuromodulation, Medtronic, Fridley, MN"
      ],
      "name": "A Shi"
    },
    {
      "affiliations": [
        "Neurovascular, Medtronic, Irvine, CA"
      ],
      "name": "E Fahimi"
    },
    {
      "affiliations": [
        "Neuromodulation, Medtronic, Fridley, MN"
      ],
      "name": "P Falkner"
    },
    {
      "affiliations": [
        "Neurosurgery, UC San Diego, La Jolla, CA"
      ],
      "name": "A Khalessi"
    }
  ],
  "title": "E-027 Long term pre-clinical evaluation of a patient specific closed loop endovascular vagus nerve stimulation system",
  "uid": "84429f94-473f-528d-8560-01a317ac35e0"
}