Occlutech Sizing Balloon - Catheter, intravascular, morphological measurement

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Life Systems Medical Pty Ltd

Class:

Class III

Manufactured by:

Occlutech GmbH Winzerlaer Strasse 2, Jena, 07745 Germany

Therapeutic area:

44889 - Catheter, intravascular, morphological measurement

Therapeutic indications:

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.

Authorization status:

A

Authorization date:

2012-12-04