Boston Scientific’s vice president (VP) of rhythm management, Caroline Bravo, speaks to Cardiac Rhythm News about the arrival of pulsed field ablation (PFA) for atrial fibrillation, and her expectations for the technology in the coming year.
How much of a priority area is PFA for Boston Scientific within the rhythm management field?
PFA is not just a priority, it’s a transformational advancement in a field where radiofrequency (RF) ablation and cryoablation have been the norm for decades. We’ve been deeply invested in PFA for years, recognising its potential to redefine ablation procedures for atrial fibrillation (AF). This feels like the paradigm shift we saw with drug-eluting stents in interventional cardiology—a true game-changer.
Will there be a need for all three of these ablation modalities in future?
It’s a key question, and one that we continually debate and model. While RF and cryoablation have been effective therapies to treat AF for years, the FARAPULSE PFA System is leading the way with the most robust clinical and real-world data. We have treated over 200,000 patients with the system and, additionally, are building strong clinical evidence on use of the Farapulse PFA system for treatment of persistent AF (see data from the ADVANTAGE AF trial here). These data demonstrate the long-term safety and effectiveness of Farapulse in AF, and we’re committed to generating further evidence on the long-term clinical benefits of PFA. While our immediate focus is AF, the potential for PFA in other arrhythmias is exciting.
What are the important questions that need to be answered on pulsed field ablation?
Physicians rightly demand evidence—robust, peer-reviewed data on safety, efficacy and efficiency. With so many emerging PFA technologies, understanding the nuances of each system is crucial as no two PFA systems are the same. That’s where Boston Scientific differentiates. ADVANTAGE AF landmark trial, along with the ADVENT trial, provides a wealth of positive clinical evidence supporting the Farapulse PFA system, while AVANT GUARD is exploring its use as a first line treatment for persistent AF. We’re not just talking about the potential of PFA; we’re aiming to expand the population that could benefit from PFA. Our commitment to clinical leadership in this space is unwavering and we are addressing the important questions by providing clinical evidence.
Is it a positive to have so many companies pursuing PFA?
Absolutely. Competition drives innovation and ultimately benefits patients. It validates the potential of PFA and pushes us all to be better. For Boston Scientific, it’s an opportunity to showcase the unique strengths of Farapulse PFA: its purpose-built design, its extensive clinical data, its proven safety and efficacy profile. We recently received CE mark for the Farawave NAV PFA Catheter, which combines mapping and ablation capabilities in a single unique catheter, providing physicians with even more workflow options.
We’re confident in our technology and believe it offers a compelling value proposition for physicians and patients alike. We welcome the competition– it allows us to highlight the key differentiators of the Farapulse PFA System, and our commitment to advancing the field of PFA.
