Boston Scientific Begins Study of Farawave PFA Nav Catheter, Software Module

Boston Scientific has begun the NAVIGATE-PF study of its Faraview software module when it’s used to visualize and track the Farawave Nav pulsed field ablation (PFA) catheter to treat paroxysmal and persistent atrial fibrillation (AF).
 
In a PFA 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 surrounding structures. Before PFA, a separate cardiac mapping catheter might be used to examine and analyze the heart’s electrical patterns in order to plan the PFA applications.
 
Boston Scientific’s Farapulse PFA system earned U.S. Food and Drug Administration (FDA) approval earlier this year.
 
The Farawave Nav PFA catheter adds magnetic navigation to the Farawave PFA catheter for detailed mapping and PFA therapy in the same device. The mapping data is displayed via the Faraview software module for a tailored mapping solution.
 
The NAVIGATE-PF study will enroll about 30 patients with paroxysmal or persistent AF. All patients will have cardiac mapping performed. Paroxysmal AF patients will receive pulmonary vein isolation and those with persistent AF will have additional posterior wall isolation at the performing physician’s discretion.
 
Ignacio García-Bolao, M.D., Ph.D., study investigator and director of cardiology and cardiovascular surgery, Clinica Universidad de Navarra, Pamplona, Spain, said creating a detailed cardiac map during ablation can improve guidance, lower fluoroscopy times, and help to assess the location of energy delivered.
 
“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,” Dr. García-Bolao said.
 
“This study seeks to build on the compelling performance of the FARAPULSE PFA System by providing an integrated mapping and navigation experience for physicians,” added Brad Sutton, MD, 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 expects U.S. regulatory approval for the Farawave Nav PFA catheter and Farawave software module in H2 2024.