Device Dossier

Passeo-18 Lux Paclitaxel-releasing PTA balloon catheter - Peripheral angioplasty balloon catheter, drug-eluting

Device Dossier for Passeo-18 Lux Paclitaxel-releasing PTA balloon catheter - Peripheral angioplasty balloon catheter, drug-eluting (Peripheral…

Intended purpose

Used to dilate de novo or restenotic lesions in the infrainguinal arteries.

Functional description

Passeo-18 Lux is a peripheral transluminal angioplasty (PTA) catheter for dilatation of stenotic segments in infrainguinal arteries with simultaneous local release of the antiproliferative ancillary substance (Paclitaxel), which is delivered to the vessel wall upon inflation of the balloon.

TGA Public Summary