Device Dossier

NUCLEUS-X Percutaneous Transluminal Valvuloplasty Catheter - Catheter, valvuloplasty, balloon dilatation

Device Dossier for NUCLEUS-X Percutaneous Transluminal Valvuloplasty Catheter - Catheter, valvuloplasty, balloon dilatation (Catheter, valvuloplasty,…

Intended purpose

Intended for Percutaneous Transluminal Valvuloplasty (PTV) for mitral and aortic position and centered angioplasty applications. The use of this catheter is particularly indicated in stenosis where difficulty in balloon positioning during inflation is experienced.

Functional description

Percutaneous Transluminal Valvuloplasty (PTV) catheter with single dilation balloon on a coaxial catheter shaft. This balloon has a smaller waist segment at its midpoint to facilitate locking into the valve or other area to be dilated. This waist area will expand to 90% of the rated balloon diameter upon injection of the inflation volume. The catheters inner tip is made of thermoplastic tubing marked with three radiopaque markers to define balloon position.

TGA Public Summary