The Pulsed-Field Ablation Race Heats Up

Boston Scientific had a notable development this week.  

The company received a CE Mark label expansion for its FARAPULSE platform, allowing the pulsed-field ablation system to treat patients with persistent atrial fibrillation (AFib). The approval covers the FARAWAVE and FARAWAVE NAV catheters and follows results from the ADVANTAGE AF clinical trial, where the technology met its primary safety and efficacy endpoints.

The update arrives at an important moment for pulsed-field ablation. The PFA market only began to take shape in 2024, yet competition has intensified quickly. Expanding indications represent one of the most direct ways for companies to grow their share of this rapidly developing market.

Before looking at how the competitive landscape is shifting, it helps to understand what the persistent AFib indication adds to the overall opportunity.

Expansion of the Addressable AFib Population

AFib affects an estimated 60 million people worldwide, according to the Global Burden of Disease study. Clinically, these patients are typically grouped into three categories based on how long the irregular rhythm persists:

• Paroxysmal AFib involves sudden, temporary episodes that resolve on their own within 48 hours to seven days. 
• Persistent AFib refers to episodes that last longer than seven days and do not resolve on their own. 
• Permanent AFib represents a chronic rhythm disorder where the heart remains in AFib indefinitely.

Until this label expansion, PFA was indicated for paroxysmal AFib. Based on the results of the Realise AF survey, that’s only about 27% of patients who are eligible for a PFA procedure. According to the study, the AFib population breakdown is as follows:

• Paroxysmal AFib: 26.5%
• Persistent AFib: 23.8%
• Permanent AFib: 49.6%

That last number is one worth sitting with; almost half of all AFib patients have permanent AFib, which is not currently eligible for ablation. However, adding persistent AFib nearly doubles the number of patients eligible for pulsed-field ablation therapy.

With this label expansion, Boston Scientific is now able to go after roughly half of the European market.

Market Size and Procedure Growth

The broader cardiac ablation market is already substantial.

LSI estimates that about 1.6 million cardiac ablation procedures are performed worldwide each year using radiofrequency, cryoablation, and pulsed-field ablation technologies.

Of those procedures, more than 300,000 are already performed using PFA. 

In terms of market size, the market is valued at $6.5 billion. We’re looking at the sum of sales for all ablation devices, as PFA is having a cannibalizing effect on radiofrequency, and especially on cryoablation.

We’re looking at market growth in excess of 30%. With billions of dollars in device revenue and strong procedural expansion, it is no surprise that the competitive race is moving quickly.

Competition in the Pulsed-Field Ablation Market

Boston Scientific gained an early lead when FARAPULSE received regulatory approval in 2024. That timing helped the company establish a strong commercial position before competitors launched their own systems.

Since then, the field has filled rapidly. By the end of 2025, Abbott, Johnson & Johnson, and Medtronic had all received regulatory approval for pulsed-field ablation devices.

Boston Scientific is still estimated to control more than half of the PFA market. Its electrophysiology business has grown significantly since the introduction of FARAPULSE.

However, competition is beginning to show. In the fourth quarter of 2025, the company missed revenue expectations for its electrophysiology segment, which raised investor concerns about potential market share pressure.

Management noted that some share movement was expected but reaffirmed its goal of growing faster than the overall electrophysiology market in 2026.

Medtronic currently markets two PFA platforms, PulseSelect and Affera. Analysts from Needham and Citi have suggested that Affera may take a bite out of FARAPULSE. Medtronic also holds approval in the United States for treating persistent AFib. In its most recent quarter, the company reported 80% growth in its cardiac ablation business.

Abbott entered the market later with its Volt PFA system, which received FDA approval in December 2025. The platform launched with indications for both paroxysmal and persistent AFib. Abbott is also pursuing a dual energy strategy that combines radiofrequency and PFA capabilities. The company has a legacy position as the second-largest competitor in the cardiac ablation landscape, due to its EnSite mapping system.

Johnson & Johnson participates through Biosense Webster. Its VARIPULSE platform integrates with the CARTO mapping system, which is used in more than half of electrophysiology procedures worldwide. The company is also developing a next-generation platform called OMNYPULSE.

What’s Next for PFA?

The persistent AFib indication marks an important step for Boston Scientific, but additional growth opportunities remain for pulsed-field ablation.

Continued conversion of procedures from radiofrequency and cryoablation will expand adoption. International markets also represent a major opportunity, particularly in regions such as Japan and China.

Another potential catalyst is ventricular tachycardia (VT). While still early, several companies, including Field Medical, Medtronic, and Boston Scientific, are exploring PFA applications for VT.

For now, Boston Scientific maintains the lead. The pulsed-field ablation market is expanding quickly, and competition from Medtronic, Abbott, and Johnson & Johnson continues to intensify. Whether Boston Scientific can maintain its advantage will become clearer as the year goes on.