Boston Scientific Begins Pulsed Field Ablation Catheter Study

The company expects U.S. regulatory approval in the second half of 2024.

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Boston Scientific  has initiated the NAVIGATE-PF study of the FARAVIEW Software Module when it is used to visualize and track the FARAWAVE Nav Pulsed Field Ablation (PFA) Catheter for the treatment of patients with paroxysmal and persistent atrial fibrillation (AF). The FARAVIEW technology and the FARAWAVE Nav catheter expand the capabilities of the FARAPULSE PFA System through integration with our cardiac mapping system.

In a pulsed field cardiac ablation procedure, a catheter is guided into the heart to administer targeted non-thermal electrical fields that selectively treat heart tissue cells, while avoiding damage to nearby structures. Before PFA therapy application, a physician might employ a separate cardiac mapping catheter to examine and analyze the heart's electrical patterns to plan the PFA applications. The FARAWAVE Nav PFA Catheter adds magnetic navigation capabilities to the current FARAWAVE PFA catheter, enabling detailed mapping and PFA therapy within the same device. This mapping data is visualized using the new FARAVIEW Software Module, offering a tailored mapping solution for procedures with the FARAPULSE PFA System.

In the prospective, single-arm, open-label, multi-center NAVIGATE-PF study, approximately 30 patients at several European centers who live with paroxysmal or persistent AF will be enrolled. All patients in the study will have cardiac mapping performed during their procedures. Those living with paroxysmal AF will undergo pulmonary vein isolation, while patients with persistent AF will undergo additional posterior wall isolation at the discretion of the physician performing the procedure.

Boston Scientific anticipates U.S. regulatory approval of the FARAWAVE NAV PFA Catheter and the FARAVIEW Software Module in the second half of 2024.

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