Device Dossier

FARADRIVE Steerable Sheath - Catheter, intravascular, guiding

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

Intended purpose

The FARADRIVE Steerable Sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum. The deflectable sheath facilitates positioning of the FARAWAVE Pulsed Field Ablation Catheter.

Functional description

The FARADRIVE Sheath is used to facilitate left atrial access and to help guide the FARAWAVE Catheter to the intended targets to perform Pulmonary Vein isolation. The FARADRIVE Sheath consists of a Steerable Sheath and a Dilator. The Steerable Sheath has a 13 French inner diameter with single plane deflection and active straightening which allows the shaft to return to a zero-degree deflection position

TGA Public Summary