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,…
- GMDN category: Catheter, valvuloplasty, balloon dilatation
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.