Device Dossier

TrapIT Trapping Balloon Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for TrapIT Trapping Balloon Catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon…

Intended purpose

The TrapIT Trapping Balloon Catheter is indicated to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. TrapIT Trapping Balloon is not intended for use outside of the guide catheter.

Functional description

TrapIT has an integrated shaft system and a balloon near the distal tip. The shaft has a lumen used for inflation of the balloon with contrast medium. A tactile feedback stop is integrated in the shaft. The shaft of the 100cm compatible TrapIT has a shaft depth marking that aid in gauging balloon catheter position relative to the guiding catheter tip when used in 90cm guide catheters. The balloon catheter does not incorporate a lumen for distal dye injections and distal pressure measurements

TGA Public Summary