Device Dossier

True Dilatation Balloon Valvuloplasty Catheter - Catheter, valvuloplasty, balloon dilatation

Device Dossier for True Dilatation Balloon Valvuloplasty Catheter - Catheter, valvuloplasty, balloon dilatation (Catheter, valvuloplasty, balloon…

Intended purpose

The True Dilatation Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

Functional description

An over-the-wire coaxial catheter with a balloon fixed at the tip. The catheter has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon is non-compliant designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque marker bands are provided for fluoroscopic positioning of the device across the aortic valve.

TGA Public Summary