Device Dossier

PACEL Flow Directed Pacing Catheter (with Peel-Away Introducer with needle) - Catheter, cardiac, balloon, pacing electrode

Device Dossier for PACEL Flow Directed Pacing Catheter (with Peel-Away Introducer with needle) - Catheter, cardiac, balloon, pacing electrode (Catheter,…

Intended purpose

PACEL™ Flow Directed Pacing Catheters with Needle/Introducer are indicated for use in temporary, transvenous right ventricular pacing.

Functional description

The Flow Directed Pacing Catheter is designed to establish temporary right ventricular pacing with or without fluoroscopy guidance for placement. Electrodes at the catheter tip enable ECG monitoring and bipolar pacing. An inflatable balloon allows for flow directed positioning in the right ventricle without fluoroscopy guidance and aids the operator in crossing the tricuspid valve. The balloon is deflated, and the catheter is advanced to the right ventricular apex.

TGA Public Summary