Occlutech Sizing Balloon - Catheter, intravascular, morphological measurement

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

Life Systems Medical Pty Ltd

Klasse:

Class III

Fremstillet af:

Occlutech GmbH Winzerlaer Strasse 2, Jena, 07745 Germany

Terapeutisk område:

44889 - Catheter, intravascular, morphological measurement

Terapeutiske indikationer:

The balloon contains three X-ray compatible marker bands which function as radiographic measurement reference. The balloon is introduced transcutaneously over a guidewire to the defect and inflated until either a slight constriction is identified or blood flow stopped. Two different methods can be used to carry out a measurement with the sizing balloon: Radiography or echocardiography. The Occlutech Sizing Balloon is intended to assist determining the size of a cardiac septal defect. Used in combination with radiographic or echocardiographic imaging, the Occlutech Sizing Balloon is intended to aid in selecting an appropriate size for a cardiac implant for the closure of a septal defect. The Occlutech Sizing Balloon is intended for venous access, used without a guide catheter and introduced directly via a guide wire.

Autorisation status:

A

Autorisation dato:

2012-12-04