LICOX Combined Oxygen and Temperature Probe, CC1.P1 - Electrode, ion selective, oxygen

Available from:

Integra Neurosciences Pty Ltd

Class:

Class III

Manufactured by:

Integra NeuroSciences Implants SAS 2905 Route Des Dolines, Sophia Antipolis, Cedex, 06921 France

Therapeutic area:

30204 - Electrode, ion selective, oxygen

Therapeutic indications:

The combined oxygen and temperature probe may be used for monitoring of oxygen partial pressure as well as temperature in the cerebral white matter. The probe may be implanted after craniotomy through a burr or drill hole at the margin of an existing bone flap. The oxygen sensing starts 4 to 6 mm from the tip of the probe. The temperature sensing part starts 13 to 15 mm from the end of the probe?s oxygen sensing part. The system is designed for no more than five days of continuous monitoring A flexible sensor probe that is part of the Licox Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. Licox System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.

Authorization status:

A

Authorization date:

2014-01-06