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Boston Scientific wins CE mark for Farapulse Nav mapping tech

February 17, 2025 By Sean Whooley

Boston Scientific Farapulse Farawave full system
The Farapulse Farawave catheter and Faraview software. [Image courtesy of Boston Scientific]
Boston Scientific announced today that it received CE mark for its navigation-enabled Farawave Nav ablation catheter and Faraview software.

Farawave Nav and the Faraview software make up part of the company’s Farapulse pulsed field ablation (PFA) system. Boston Scientific initially won FDA approval for Farapulse in January 2024. In doing so, it became second company to earn an FDA nod for PFA that treats AFib. Medtronic picked up the first approval for PFA to treat paroxysmal and persistent AFib in December 2023.

Farawave Nav and Faraview combine to provide visualization for cardiac ablation procedures to treat AFib. They’re compatible exclusively with Boston Scientific’s existing cardiac mapping technology and its latest offering, the Opal HDx mapping system.

Boston Scientific won FDA approval for the catheter and software last October.

“By integrating innovative mapping technology into a single catheter, the Farapulse PFA system transforms the treatment of atrial fibrillation and sets a new benchmark in clinical innovation and therapeutic care ,” said Caroline Bravo, VP, Rhythm Management EMEA, Boston Scientific. “The Farawave Nav ablation catheter and Faraview software module, specifically designed for the Farapulse electroporation system, offer a complete and efficient solution for AFib mapping and ablation, improving procedural efficiency and accuracy. ”

More about the latest PFA offerings from Boston Scientific

Farawave Nav builds upon the current Farwave catheter by adding magnetic navigation capabilities. This enables cardiac mapping and PFA delivery within a single integrated catheter and minimizes the need for additional device exchanges. Boston Scientific says this simplifies procedures by combining mapping nad electroporation in a single catheter, facilitating workflows.

Faraview software depicts mapped procedures with Farapulse, providing a dynamic view of catheter placement, shape and rotation. It magnetically tracks the catheter to give physicians a view of where pulsed fields have been applied. They can visualize cumulative therapy delivery to guide ablation strategy.

The company’s FieldTag automatic labeling technology helps the module identify areas where elctroporation has been performed. This facilitates the planning, execution and validation of the procedure.

“The combination of the Faraview module and the Farawave Nav catheter represents a significant milestone for physicians. The combined navigation and visualization capabilities of these technologies can improve guidance, reduce fluoroscopy time, and enable accurate assessment of energy delivery during pulmonary vein isolation procedures,” said Dr. Garcia Bolao, head of cardiology and cardiac surgery at Clínica Universidad de Navarra, Spain. “With high-quality mapping and an optimized process, we can improve the effectiveness of interventions and deliver better outcomes for our patients.”

Filed Under: Applications, Cardiology, Catheters, CE Mark, Pulsed Field Ablation, Regulatory, Technologies & Devices Tagged With: Boston Scientific

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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