Boston Scientific has initiated a clinical study of its FARAVIEW software module, used in conjunction with its FARAWAVE Nav pulsed field ablation (PFA) catheter to treat both paroxysmal and persistent atrial fibrillation (AF).
The FARAWAVE Nav PFA catheter integrates magnetic navigation into the existing FARAWAVE PFA catheter, allowing comprehensive mapping and PFA therapy in one device. Mapping results are displayed via the FARAVIEW software module, providing a customised mapping solution for procedures using the FARAPULSE PFA system.
The FARAPULSE PFA system is a treatment option for people with drug-refractory, recurrent, symptomatic, paroxysmal AF. It is a substitute for traditional thermal ablation treatments, using non-thermal electric fields to selectively ablate heart tissue while minimising damage to adjacent structures.
The system, which includes the FARAWAVE Ablation Catheter, the FARASTAR Ablation Generator, and the FARADRIVE Steerable Sheath, which is used in conjunction with the VersaCross Connect Access Solution, received approval from the US Food and Drug Administration (FDA) in February 2024.
The NAVIGATE-PF study will enrol 30 subjects with paroxysmal AF, a type of irregular heart rhythm that occurs intermittently, or persistent AF, a sustained irregular heart rhythm that lasts for more than seven days.
Paroxysmal AF patients 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 expects that the FARAWAVE NAV PFA Catheter and the FARAVIEW Software Module will receive regulatory approval in the second half of 2024, according to the 7 April press release.
In the announcement accompanying the study initiation, study investigator Ignacio García-Bolao said: “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 December 2023, tech giant Medtronic secured FDA approval for its PulseSelect PFA system, a month after receiving the European Conformité Européenne (CE) mark. PulseSelect was the first PFA catheter to be commercially available in the US.
