Boston Scientific Corp. (BSX) said it has received U.S. Food and Drug Administration approval for the navigation-enabled FARAWAVE NAV Ablation Catheter for the treatment of paroxysmal atrial fibrillation (AF) and FDA 510(k) clearance for the new FARAVIEW Software, which will combine to provide visualization for cardiac ablation procedures with the FARAPULSE Pulsed Field Ablation (PFA) System.
Boston Scientific noted that the technologies are compatible exclusively with its existing cardiac mapping technology and the company's latest offering, the OPAL HDx Mapping System.
The company said it will immediately launch the FARAWAVE NAV Ablation Catheter and FARAVIEW Software in the U.S.
According to the company, the latest advancement within the Boston Scientific PFA portfolio, the FARAVIEW Software magnetically tracks the FARAWAVE NAV Ablation Catheter, which allows physicians to see where pulsed fields have been applied and visualize cumulative therapy delivery to guide ablation strategy.
Delivery of PFA with the FARAWAVE NAV Ablation Catheter can be tracked through automated tagging technology, which is intended to assist physicians in planning, executing and confirming application of therapy by showing the approximate pulsed field locations within the heart, based on the catheter's position, the company said.
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