Saluda Medical MCS - Stimulator, electrical, analgesic, spinal cord

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

Saluda Medical Pty Ltd

classe:

Class I

Fabriqué par:

Saluda Medical Pty Ltd Level 1 407 Pacific Highway, ARTARMON, NSW, 2064 Australia

Domaine thérapeutique:

36007 - Stimulator, electrical, analgesic, spinal cord

indications thérapeutiques:

External Trial Stimulator EXPORT ONLY Stimulator, electrical, analgesic, spinal cord. For use under a first in human non-significant risk clinical study in the USA evaluating the incorporated feedback control using Evoked Compound Action Potentials (ECAP) to aid in the accurate positioning of paddle Spinal Cord Stimulation (SCS) leads. ). The device attaches to the paddle lead (not part of our device or system) being implanted in the epidural spaces of the spinal cord into which signals and/or energy is inductively coupled from outside the body and the ECAP measures are recorded and used to position the lead. Once implanted the lead is then coupled with an analgesic spinal cord stimulators to treat acute and/or chronic intractable pain, where the use of drug therapy is undesirable or no longer effective.

Statut de autorisation:

A

Date de l'autorisation:

2014-04-15