Pulsed Field Ablation System Offers Unique Alternative to Standard-Of-Care Thermal Ablation Treatment

Millions of individuals are living with drug-resistant, recurrent, symptomatic, and intermittent atrial fibrillation (AF), for which thermal ablation is currently the standard treatment. In a typical ablation procedure, a catheter is inserted into the heart and uses extreme temperatures, either hot or cold, to destroy specific areas linked to abnormal heart rhythms. However, this method carries the risk of damaging adjacent structures. Now, a groundbreaking system presents a new alternative for isolating pulmonary veins in patients with drug-refractory, symptomatic, persistent AF, offering a distinct approach from the conventional thermal ablation treatments.

The FARAPULSE Pulsed Field Ablation (PFA) System from Boston Scientific Corporation (Marlborough, MA, USA) employs tissue-selective, non-thermal electric fields to ablate heart tissue while minimizing the risk of harm to surrounding areas. This system includes the FARAWAVE Ablation Catheter, the FARASTAR Ablation Generator, and the FARADRIVE Steerable Sheath. Additionally, it features the VersaCross Connect Access Solution, designed to ensure safe and efficient access to the heart’s left side during procedures. The FARAWAVE catheter is versatile and capable of treating various pulmonary vein anatomies. It's an over-the-wire catheter that can be shaped into basket or flower configurations, adapting to individual patient anatomies. This adaptability enhances ease of use for physicians and supports consistent outcomes across different operators.

The system’s safety, efficacy, and efficiency are supported by strong clinical evidence and extensive real-world usage. The pivotal ADVENT clinical trial, the first to directly compare this system's efficacy and safety against standard-of-care ablation, reported that the device was as safe and effective as traditional thermal ablation. Notably, it achieved shorter ablation times and required a short learning curve for physicians. Moreover, data from the MANIFEST-17K registry involving over 17,000 patients has shown ongoing real-world safety, with no cases of permanent phrenic nerve palsy, pulmonary vein stenosis, or esophageal injury reported. Boston Scientific has gained U.S. Food and Drug Administration (FDA) approval for the FARAPULSE PFA System and is set to immediately introduce the system in the U.S. market. The company is also working on a navigation-enabled version of the FARAWAVE catheter, along with the FARAVIEW Software Module, and anticipates regulatory approval by 2024.

"The approval of the FARAPULSE PFA System marks an important milestone for the millions of people living with paroxysmal AF and is an incredible opportunity to bring the first PFA system designed and built solely for this type of ablation therapy to physicians in the U.S.," said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific. "A high bar has been set by performance of the system in clinical and commercial settings – where more than 40,000 patients have been treated to date – and we look forward to continuing to lead the way with this differentiated technology in the growing PFA space."

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