The NAVIGATE-PF study evaluates Faraview when used to visualize and track the Farawave Nav PFA catheter for treating AFib. Faraview and the Farawave Nav catheter expand the capabilities of the Boston Scientific Farapulse PFA system through cardiac mapping integration.
On Jan. 31, Boston Scientific won FDA approval for the use of Farapulse in treating drug-refractory, recurrent, symptomatic, paroxysmal AFib. It became the second company to receive FDA approval for a pulsed field ablation (PFA) system that treats AFib after Medtronic. Boston Scientific Chief Medical Officer Ken Stein told MassDevice what comes next for the system shortly after approval. He also outlined the importance of catheter design.
The company plans to enroll approximately 30 patients at several European centers with paroxysmal or persistent AFib. All patients will undergo cardiac mapping during their procedures. Those with paroxysmal AFib will also undergo pulmonary vein isolation and patients with persistent AFib 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 Dr. Brad Sutton, M.D., chief medical officer, AFib 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.”
More about the new Boston Scientific study
In a PFA procedure, the catheter goes into the heart to administer targeted non-thermal electrical fields. Physicians guide the catheter to selectively treat heart tissue cells and avoid damage to nearby structures. Before PFA therapy, a physician might employ a separate mapping catheter to examine and analyze the heart’s electrical patterns.
With the Farawave Nav catheter, they can use magnetic navigation to deliver detailed mapping and PFA therapy within the same device. They can visualize the mapping data in the Faraview software module for procedures with Farapulse.
On LinkedIn, Boston Scientific’s Global President of Electrophysiology, Nick Spadea-Anello, called the study a “significant milestone.” He said it helps the company expand the capabilities of Farapulse and investigate how integrated cardiac mapping could enhance patient outcomes.
Boston Scientific expects FDA approval for the Farawave catheter and Faraview software in the second half of 2024.
“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 Dr. Ignacio García-Bolao, 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.”
