Device Dossier

TrapLiner catheter - Catheter, intravascular, guiding

Device Dossier for TrapLiner catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Teleflex Medical). ARTG…

Intended purpose

TrapLiner is a product that incorporates (i) utility and functionality of a guide extension tool with (ii) capacity for trapped exchanges of over-the-wire interventional equipment. As such, TrapLiner’s intended use is to facilitate complex percutaneous coronary and peripheral interventional procedures by both providing (i) support and access functions for device delivery and (ii) the security and efficiency of trapped exchanges. The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature, and to assist in crossing de novo coronary chronic total occlusions (CTO).

Functional description

TrapLiner catheter is a rapid exchange guide extension catheter with a guidewire trapping balloon. Compatible with 6F, 7F, and 8F guide catheters. It has a proximal stainless steel pushrod covered on the distal portion with a semicircular polymer. The trapping balloon is located proximal to the semi-circular polymer for trapping guidewires against the inner wall of a guide catheter. The pushrod is followed distally by a hydrophilic coated full-round guide extension section.

TGA Public Summary