Boston Scientific Corporation has announced it has received CE-mark approval for its navigation-enabled Farawave Nav ablation catheter in the treatment of paroxysmal atrial fibrillation (AF) and for its new Faraview software. Both technologies will integrate and expand mapping option capabilities for cardiac ablation procedures using the Farapulse pulsed field ablation (PFA) system, which the company claims is the most clinically proven PFA system for the treatment of AF and has already benefitted 200,000 patients globally.
These technologies are compatible exclusively with Boston Scientific’s existing cardiac mapping technology and the company’s latest offering, the Opal HDx mapping system, a press release details.
According to Boston Scientific, electrophysiologists today might use a separate mapping catheter before a cardiac PFA procedure to study the heart’s electrical patterns and plan treatment for each patient—but the Farawave Nav ablation catheter advances on the current Farawave catheter by adding magnetic navigation, allowing cardiac mapping and PFA therapy to be done with a single catheter, and reducing the need for extra device changes. Mapped procedures with the Farapulse PFA system are displayed visually for doctors using the Faraview software, which provides a dynamic view of catheter placement, shape, and rotation.
“The Farapulse PFA system has transformed the way we treat atrial fibrillation, and integrated mapping technology with a single catheter solution will set a new standard for clinical innovation and therapy delivery,” said Caroline Bravo, Boston Scientific’s vice president of rhythm management for Europe, the Middle East and Africa (EMEA). “The Farawave Nav ablation catheter and Faraview software are designed specifically for the Farapulse PFA system, and have the potential to increase workflow options, maintain efficiency and enhance the treatment physicians can provide to patients living with AF.”
The Faraview software magnetically tracks the Farawave Nav ablation catheter, enabling physicians to visualise where pulsed fields have been applied and observe cumulative therapy delivery to guide ablation strategy. PFA delivery with the Farawave Nav ablation catheter can be tracked through automated Fieldtag technology, which is designed to assist physicians in planning, executing and confirming therapy application by indicating the approximate pulsed field locations within the heart based on the catheter’s position, Boston Scientific states.
“Atrial fibrillation can significantly affect a patients’ quality of life, causing symptoms such as fatigue, palpitations [and] breathlessness,” said Gábor Széplaki (Mater Private Hospital, Dublin, Ireland). “Some patients cannot manage their symptoms with medication alone. If medication is not effective, we can consider a minimally invasive technology like Farapulse pulsed field ablation system in combination with the new Faraview mapping software. Advanced technology like this helps to enhance our understanding of optimal treatment for atrial fibrillation. Minimally invasive technologies like Faraview mapping enhances understanding of their atrial fibrillation to enable treatment using the Farapulse pulsed field ablation system.”
