Devices

The VNS Therapy System, a left chest pulse generator with a lead on the left vagus nerve. Approved in the EU for epilepsy in 1994, by the FDA in July 1997, and by the FDA for treatment-resistant depression in July 2005. Traced to the FDA's own approval records.

Device — Peripheral nerve

Vagus nerve stimulation (FDA record)

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VNS · vagus nerve · epilepsy · depression · Cyberonics · LivaNova · FDA · peripheral nerve · human

Vagus nerve stimulation (FDA record)

One-line verdict: The first implanted autonomic nerve stimulator approved for epilepsy in the US, with a regulatory trail that can be read straight from the FDA.

Quick tags: Stimulation · Peripheral nerve · Human · FDA approved 1997

Overview

What it is: The VNS Therapy System. The FDA describes it as an implantable pulse generator and a lead, with an external programming system used to change stimulation settings. Electrical signals go from the pulse generator to the vagus nerve through the lead. The pulse generator is surgically placed in the left chest and the lead is attached to the left vagus nerve. Patients are given magnets; holding one over the pulse generator turns programmed stimulation off, and stimulation resumes when the magnet is removed.

Regulatory record (FDA premarket approval P970003):

  • Applicant: Cyberonics, Inc. at the time of the approval documents; the current FDA record lists LivaNova USA, Inc., 100 Cyberonics Blvd, Houston.
  • Received 27 January 1997. Decision date 16 July 1997, with expedited review granted. Neurology advisory committee.
  • Approved system: the NeuroCybernetic Prosthesis (NCP) System, including the Model 100 NCP Generator, the Model 300 Series NCP Vagus Nerve Stimulation Lead, the Model 400 Tunneling Tool and accessories.
  • FDA indication for epilepsy: adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with medically refractory partial onset seizures.
  • Outside the US: the FDA summary says the system has been approved for epilepsy in all countries of the European Union since June 1994. CE Mark for depression followed in March 2001, and Cyberonics began distributing for depression in Canada in April 2001.
  • Depression: supplement P970003/S50. Panel recommendation 15 June 2004. Notice of approval to the applicant 15 July 2005. The indication is adjunctive long-term treatment of chronic or recurrent depression in patients 18 or older in a major depressive episode who have not responded adequately to four or more antidepressant treatments. Models named include the Pulse Model 102 and Pulse Duo Model 102R generators and the Model 302 lead.

Limits: Sources read here are FDA records. They give model numbers, not lead or generator dimensions, so none are listed and there is no 3D model. Later indications and device generations are not covered.

Spec Card Grid

System

  • Implant: pulse generator (left chest) and lead (left vagus nerve)
  • External: programming system, patient magnet
  • 1997 models: Model 100 generator, Model 300 series lead
  • 2005 models: Model 102 and 102R generators, Model 302 lead

Regulatory

  • EU, epilepsy: since June 1994
  • FDA, epilepsy: 16 July 1997 (P970003)
  • FDA, depression: notice of approval 15 July 2005 (P970003/S50)

Evidence and limits

  • Not covered here: dimensions, battery details, later models; no 3D model yet

References