Boston Scientific Initiates NAVIGATE-PF Study of the FARAWAVE™ Nav Pulsed Field Ablation Catheter and FARAVIEW™ Software Module

MARLBOROUGH, Mass., April 8, 2024 /--Boston Scientific Corporation (NYSE: BSX) 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.

"Creating a detailed cardiac map during an ablation procedure can improve guidance, reduce fluoroscopy times and assist physicians in assessing the location of energy delivered, which may improve patient outcomes," said Ignacio García-Bolao, M.D., Ph.D., study investigator and director of cardiology and cardiovascular surgery, Clinica Universidad de Navarra, Pamplona, Spain. "Through this study, we hope to identify the procedural benefits of the FARAWAVE Nav catheter, which can both map and ablate, alongside technology that allows for magnetically-tracked, dynamic visualization of a patient's cardiac anatomy and catheter configuration."

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.

"This study seeks to build on the compelling performance of the FARAPULSE PFA System by providing an integrated mapping and navigation experience for physicians," said Brad Sutton, M.D., chief medical officer, AF Solutions, Boston Scientific. "Adding navigation and visualization capabilities to this PFA system, which is leading the way in terms of safety, efficacy and efficiency, is an exciting proposition for physicians and patients alike."

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

More information on the FARAPULSE PFA System is available here.

*Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.
** Dr. Ignacio Garcia-Bolao is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release.

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