PulseSelect™ Pulsed Field Ablation Loop Catheter - Cardiac irreversible electroporation system catheter

Intended purpose

The intended purpose of the PulseSelect PFA loop catheter is to detect electrical signals, ablate cardiac tissue, and perform cardiac stimulation during electrophysiology procedures.

Functional description

The PulseSelect Pulsed Field Ablation (PFA) loop catheter is a sterile, single use, multi-electrode catheter. It features a steering lever that allows for the deflection of the catheter’s distal end. It also features a slide control that enables that extension/retraction and deployment/retainment of the multi-electrode loop. Using an introducer sheath and guidewire ^, the catheter is typically introduced into the left atrium of the heart via the femoral access.