Device Dossier

POLARSHEATH Steerable Sheath - Catheter, intravascular, guiding

Device Dossier for POLARSHEATH Steerable Sheath - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Boston…

Intended purpose

The POLARSHEATH is intended to facilitate the placement of diagnostic and/or therapeutic intracardiac devices during percutaneous catheter ablation procedures. The sheath deflection facilitates catheter positioning. The POLARSHEATH steerable sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart.

Functional description

Single use, sterile, 12F disposable, steerable percutaneous introducer sheath designed with a valve for maneuverability and swapping of standard catheters and wires that are advanced through the sheath and into cardiac chambers. It presents a single lumen shaft, a handle to provide torque and active deflection, and a hemostasis valve. A side-port is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, and blood sampling.

TGA Public Summary