In a pulsed discipline cardiac ablation process, a catheter is guided into the center to manage focused non-thermal electrical fields that selectively deal with coronary heart tissue cells, whereas avoiding harm to close by buildings. Earlier than PFA remedy utility, a doctor would possibly make use of a separate cardiac mapping catheter to look at and analyze the center’s electrical patterns to plan the PFA purposes. The FARAWAVE Nav PFA Catheter provides magnetic navigation capabilities to the present FARAWAVE PFA catheter, enabling detailed mapping and PFA remedy throughout the similar machine. This mapping information is visualized utilizing the brand new FARAVIEW Software program Module, providing a tailor-made mapping answer for procedures with the FARAPULSE PFA System.
“Creating an in depth cardiac map throughout an ablation process can enhance steerage, cut back fluoroscopy instances and help physicians in assessing the placement of vitality delivered, which can enhance affected person outcomes,” mentioned Ignacio GarcÃa-Bolao, M.D., Ph.D., research investigator and director of cardiology and cardiovascular surgical procedure, Clinica Universidad de
Within the potential, single-arm, open-label, multi-center NAVIGATE-PF research, roughly 30 sufferers at a number of European facilities who reside with paroxysmal or persistent AF can be enrolled. All sufferers within the research can have cardiac mapping carried out throughout their procedures. These dwelling with paroxysmal AF will bear pulmonary vein isolation, whereas sufferers with persistent AF will bear further posterior wall isolation on the discretion of the doctor performing the process.
“This research seeks to construct on the compelling efficiency of the FARAPULSE PFA System by offering an built-in mapping and navigation expertise for physicians,” mentioned
Boston Scientific anticipates U.S. regulatory approval of the FARAWAVE NAV PFA Catheter and the FARAVIEW Software program Module within the second half of 2024.
Extra data on the FARAPULSE PFA System is offered right here.
Warning: Investigational Machine. Restricted by Federal (or US) legislation to investigational use solely. Not out there on the market.
Dr. Ignacio Garcia-Bolao is a paid advisor of Boston Scientific Company. He has not been compensated in reference to this press launch.
About Boston Scientific
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