Boston Scientific Corporation has has received CE mark for the navigation-enabled FARAWAVENAV Ablation Catheter for the treatment of paroxysmal atrial fibrillation (AF) and for the new FARAVIEW Software, the company has announced.
Both technologies will integrate and expand mapping option capabilities for cardiac ablation procedures using the FARAPULSE Pulsed Field Ablation (PFA) System, the most clinically proven PFA system for the treatment of AF, which has already benefited 200,000 patients globally.
These technologies are compatible exclusively with the company’s existing cardiac mapping technology and the company’s latest offering, the OPAL HDx Mapping System.
Today, electrophysiologists might use a separate mapping catheter before a cardiac PFA procedure to study the heart’s electrical patterns and plan treatment for each patient.
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, reducing the need for extra device changes.
Mapped procedures with the FARAPULSE PFA System are shown visually for doctors using the FARAVIEW Software, which provides a dynamic view of catheter placement, shape, and rotation.
Caroline Bravo is vice president, Rhythm Management EMEA, at Boston Scientific.
Bravo said: “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.
“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, 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.
Prof Gábor Széplaki added: “Atrial fibrillation can significantly affect a patients’ quality of life, causing symptoms such as fatigue, palpitations breathlessness.
“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.”
Boston Scientific will launch the FARAWAVE NAV Ablation Catheter and the FARAVIEW Software in the EMEA region.
