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

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Disponibil de la:

Saluda Medical Pty Ltd

Clasă:

Class I

Produs de:

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

Zonă Terapeutică:

36007 - Stimulator, electrical, analgesic, spinal cord

Indicații terapeutice:

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.

Statutul autorizaţiei:

A

Data de autorizare:

2014-04-15