LICOX Complete Brain Tunneling Probe Kit, IT2 - Surgical procedure kit, neurosurgical, single-use, non-medicated

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:

44063 - Surgical procedure kit, neurosurgical, single-use, non-medicated

Therapeutic indications:

The kit consists of a parenteral probe guide with integral trocar Ref VK5.2 and combined oxygen and temperature probe Ref CC1.P1. The parenteral probe guide, a small diameter plastic tube with attached trocar, is designed to be ?tunneled? under the scalp and provides fixation for the CC1.P1 probe. The probe may be implanted after craniotomy through a burr or drill hole at the margin of an existing bone flap. The system is designed for no more than five days of continuous monitoring. 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