Heart ablation is moving beyond heat and cold, and the medtech race is getting much bigger

Boston Scientific Corporation says its FARAPULSE pulsed field ablation platform has now been used to treat more than 500,000 patients globally. That is a striking scale for a technology whose first U.S. regulatory breakthrough came only in December 2023, when the U.S. Food and Drug Administration approved Medtronic’s PulseSelect system. Boston Scientific followed with FARAPULSE in January 2024, and the competitive field has since expanded considerably.

The U.S. market now includes more than one technological interpretation of PFA. Medtronic has both its circular PulseSelect system and the Affera Mapping and Ablation System with the Sphere-9 catheter, an FDA-approved focal platform capable of high-definition mapping and both pulsed field and radiofrequency energy. Johnson & Johnson has VARIPULSE, Boston Scientific has expanded FARAPULSE with additional mapping and focal-ablation components, and Abbott Laboratories entered with Volt after FDA approval in December 2025.

The commercial shift is consequently larger than a change in ablation energy. Electrophysiology companies are competing over catheter geometry, pulse waveforms, mapping integration, procedural speed, lesion durability and whether one device can map, ablate and verify treatment without repeated catheter exchanges. PFA is turning an established cardiovascular procedure into a contest over the architecture of the entire electrophysiology lab.

What is pulsed field ablation and how does it treat atrial fibrillation?

Atrial fibrillation occurs when electrical activity in the heart’s upper chambers becomes disorganised, producing an irregular rhythm that can cause palpitations, fatigue and breathlessness while increasing the risk of stroke and heart failure. Catheter ablation aims to interrupt the abnormal electrical pathways or isolate tissue responsible for initiating or sustaining those arrhythmias.

For many patients, the pulmonary veins are central to the procedure because electrical triggers commonly arise near the points where those veins enter the left atrium. Pulmonary vein isolation has therefore become a foundational ablation strategy.

Traditional radiofrequency ablation creates lesions by heating tissue, while cryoballoon systems freeze tissue. Pulsed field ablation instead exposes tissue to very short, high-voltage electrical pulses that cause irreversible electroporation, creating membrane disruption that ultimately destroys targeted cells. The FDA classifies these systems specifically as cardiac ablation devices using irreversible electroporation.

PFA is commonly described as nonthermal because irreversible electroporation rather than heating is its principal mechanism. That description should not be interpreted as meaning temperature is irrelevant to every PFA waveform or application pattern. Catheter geometry, pulse sequence, repetition and irrigation can affect both lesion characteristics and local temperature, one reason platforms need to be evaluated individually rather than treating all PFA systems as technically interchangeable. Johnson & Johnson’s 2026 VARIPULSE Pro launch, for example, specifically emphasised a new pulse sequence with a lower temperature profile.

Is pulsed field ablation safer than radiofrequency or cryoablation?

One of PFA’s most attractive characteristics is the possibility of greater tissue selectivity around structures that physicians do not want to damage. That biological rationale has sometimes produced a simplified narrative that PFA is inherently safer than thermal ablation, but the clinical evidence supports a more measured conclusion.

The pivotal ADVENT trial directly compared Boston Scientific’s FARAPULSE system with conventional radiofrequency or cryoballoon ablation in patients with paroxysmal atrial fibrillation. PFA met the prespecified criteria for non-inferiority in both effectiveness and safety. That established PFA as a credible alternative to established thermal technologies, but it did not demonstrate universal safety superiority.

Medtronic’s PULSED AF programme provides another important dataset. The FDA’s review found one primary safety event among 150 paroxysmal-AF patients and one among 150 persistent-AF patients, equivalent to 0.7% in each cohort. The events were a cerebrovascular accident in the paroxysmal group and a pericardial effusion in the persistent group.

The significance is that PFA changes the injury mechanism but does not remove the risks of catheter-based left-heart intervention. Vascular complications, stroke, tamponade, perforation and other procedural events remain possible. Additional PFA-specific concerns such as coronary spasm, haemolysis and the effects of repeated or overlapping applications are also receiving greater scrutiny as use expands.

Which pulsed field ablation systems are already FDA-approved?

Medtronic’s PulseSelect became the first FDA-approved PFA system on December 13, 2023. The approval covers drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation and persistent atrial fibrillation with episode duration of less than one year. The pivotal programme included 150 patients in each cohort.

Boston Scientific’s FARAPULSE received its original FDA approval on January 30, 2024 for paroxysmal atrial fibrillation. Its U.S. indication was subsequently expanded on July 3, 2025 to include pulmonary-vein and posterior-wall isolation in drug-refractory symptomatic persistent atrial fibrillation lasting less than one year. That July 2025 date corrects the earlier version of this feature.

Medtronic added another important architecture when the FDA approved the Affera Mapping and Ablation System with Sphere-9 on October 24, 2024. Unlike a single-shot circular PFA catheter, Sphere-9 provides high-definition mapping and can deliver either pulsed field or radiofrequency energy through the same focal lattice-tip catheter. Its U.S. indication includes drug-refractory recurrent symptomatic persistent atrial fibrillation, while radiofrequency energy can also be used for cavotricuspid-isthmus-dependent atrial flutter.

Johnson & Johnson’s Biosense Webster received FDA approval for VARIPULSE on November 6, 2024 for drug-refractory recurrent symptomatic paroxysmal atrial fibrillation. Abbott Laboratories followed on December 19, 2025 with Volt, which carries an indication covering symptomatic recurrent drug-refractory paroxysmal or persistent atrial fibrillation lasting less than one year.

Why has Boston Scientific FARAPULSE become such an important PFA platform?

Commercial scale is now one of FARAPULSE’s strongest differentiators. Boston Scientific says more than 500,000 patients have been treated globally, while its evidence programme spans more than 55 clinical trials and more than 70,000 patients represented in real-world registries. These remain company-reported figures, but they demonstrate that the platform has moved far beyond a narrowly controlled launch.

Boston Scientific has also progressively broadened what physicians can do within the FARAPULSE ecosystem. Persistent-AF approval in July 2025 added posterior-wall isolation to the established pulmonary-vein workflow. The FARAPOINT focal PFA catheter was then FDA-approved on January 12, 2026 as an adjunctive device for creating a cavotricuspid-isthmus ablation line when FARAWAVE is used to treat qualifying persistent-AF patients.

The distinction matters because the earlier version incorrectly treated August 3, 2026 as the FARAPOINT approval date. The FDA record was updated in August, but the actual approval decision occurred on January 12.

This progression reveals where the commercial competition is moving. Pulmonary vein isolation opened the PFA market, but electrophysiologists frequently need to treat arrhythmia substrates outside the pulmonary veins. A platform that can combine broad-area PFA, focal lesions, mapping and additional lesion sets can capture more of the overall procedure.

Can pulsed field ablation work for persistent atrial fibrillation?

Persistent atrial fibrillation is a more demanding target because the abnormal rhythm has become more established and the underlying atrial substrate may be more complex than in intermittent paroxysmal disease.

Regulatory approvals already show that PFA has moved into this population. PulseSelect has covered persistent AF lasting less than one year since its original U.S. approval. Medtronic’s Sphere-9/Affera system is also approved for persistent AF, FARAPULSE added the indication in July 2025, and Abbott’s Volt was approved for both paroxysmal and persistent disease under its labelled conditions.

Medtronic’s SPHERE Per-AF trial is particularly instructive because it compared the dual-energy Sphere-9/Affera system with an established radiofrequency catheter and mapping system. FDA reporting shows that 73.8% of Sphere-9 patients in the relevant analysis avoided arrhythmia recurrence through 12 months compared with 65.8% in the control group, meeting the study’s prespecified non-inferiority standard.

The broader implication is that PFA is no longer synonymous with a single-shot pulmonary-vein procedure. The competition is increasingly about how effectively electric-field technology can tackle the more complex workflows associated with persistent disease.

Could PFA become a first-line treatment before antiarrhythmic drugs?

The AVANT GUARD trial has pushed this question much closer to clinical relevance.

The randomized study assigned 310 patients with previously untreated persistent atrial fibrillation to an initial FARAPULSE strategy or antiarrhythmic drug treatment. At 12 months, the primary treatment-success endpoint was achieved in 56% of the PFA group compared with 30% of the drug group, and the study reported a similar incidence of serious adverse events between strategies. The results were published online in The New England Journal of Medicine in April 2026.

The regulatory boundary is crucial. FARAWAVE is not currently FDA-approved as first-line therapy for persistent atrial fibrillation, and Boston Scientific explicitly labels that use as investigational.

Commercially, however, the trial changes the question facing the industry. If future guidelines and regulatory indications move ablation earlier in the treatment pathway, PFA would not merely take procedural share from radiofrequency and cryoballoon systems. It could increase the number of patients reaching the electrophysiology lab before prolonged antiarrhythmic-drug therapy.

Why do mapping systems matter so much in the PFA technology race?

Ablation energy attracts the attention, but cardiac electrophysiology depends equally on knowing where the catheter is, where abnormal electrical activity originates and whether the intended lesion has actually produced electrical block.

That is why PFA competition is increasingly becoming a mapping-platform contest. Johnson & Johnson integrates VARIPULSE with CARTO 3. Abbott’s Volt connects with EnSite X. Boston Scientific has been building navigation and mapping capability around FARAWAVE NAV and its broader platform, while Medtronic’s Sphere-9 is itself an all-in-one high-definition mapping and dual-energy ablation catheter integrated with Affera.

Sphere-9 is particularly important because it demonstrates that PFA does not necessarily have to remain a separate “single-shot” workflow. The same catheter can map, deliver focal pulsed field energy, switch to radiofrequency when appropriate and remap to confirm treatment without an exchange.

For hospitals, this can turn catheter selection into an ecosystem decision. Mapping hardware, generators, software, disposables, training and workflow become interconnected, raising switching costs and giving manufacturers an opportunity to build recurring revenue around more than the ablation catheter itself.

What happened during Johnson & Johnson’s VARIPULSE U.S. rollout?

VARIPULSE provides one of the clearest reminders that PFA systems need to be evaluated individually rather than assuming a class-wide safety profile.

Johnson & Johnson temporarily paused its U.S. external evaluation and all U.S. VARIPULSE cases on January 5, 2025 after four neurovascular events were reported. The FDA later stated that four of the first 132 patients treated during the limited U.S. evaluation, roughly 3%, experienced stroke or transient ischaemic attack shortly after the procedure, above the level normally expected for this type of intervention.

The FDA classified the subsequent correction as its most serious recall type, although it did not require removal of the devices. The agency said the investigation identified differences between some procedures and the labelled instructions, including higher application counts, repeated applications at the same location and ablation beyond studied pulmonary-vein locations.

Johnson & Johnson resumed the limited U.S. release in February 2025 after concluding that the devices operated as intended and updating instructions for use. VARIPULSE remains commercially available in markets where launched, while the company introduced VARIPULSE Pro in Europe in April 2026 with a revised pulse sequence designed to shorten energy delivery and lower the temperature profile. VARIPULSE Pro is not currently approved in the United States.

The episode reinforces a critical point for PFA economics: adoption depends on repeatable safety across thousands of ordinary procedures, not merely strong results in controlled pivotal trials.

How is Abbott trying to differentiate the Volt PFA System?

Abbott entered the U.S. PFA market later but did so with a system already approved for both paroxysmal and persistent atrial fibrillation lasting less than one year. Volt uses a balloon-based catheter architecture and is integrated with Abbott’s EnSite X mapping platform. FDA approval came on December 19, 2025.

Abbott’s April 2026 data also point toward broader treatment strategies. In a CE Mark extension cohort evaluating posterior-wall isolation, the company reported an average of 4.1 applications per pulmonary vein and 10.7 applications for posterior-wall isolation, with no patient- or procedure-related complications reported in that dataset. Those are early, company-reported trial findings rather than evidence of universal procedural superiority.

Abbott is simultaneously developing TactiFlex Duo, a focal catheter capable of switching between radiofrequency and PFA. The catheter received CE Mark in Europe in January 2026, and Abbott completed enrolment in its U.S. FLEXPULSE IDE study. The FDA had also granted Breakthrough Device designation in October 2025 for an investigational ventricular-tachycardia application using PFA.

That strategy mirrors an important industry shift. The future may not be a clean battle between PFA and radiofrequency. Physicians may instead use dual-energy systems that select the mechanism according to the arrhythmia, anatomy and lesion required.

Will pulsed field ablation replace radiofrequency and cryoablation?

PFA has already passed the point at which it can reasonably be treated as an experimental alternative. Multiple FDA-approved systems are commercially available, Boston Scientific reports more than half a million FARAPULSE patients treated globally, and persistent-AF indications now extend across several competing platforms.

Yet the technology is becoming more heterogeneous as it matures. PulseSelect uses one architecture, FARAWAVE another, VARIPULSE another, and Volt another. Sphere-9 and newer European dual-energy systems show that focal PFA and radiofrequency can coexist in the same catheter rather than forcing physicians to choose one energy modality for the entire procedure.

That makes outright elimination of thermal ablation less certain than the rapid rise of PFA might suggest. Radiofrequency remains highly flexible for point-by-point lesion creation and complex anatomy, while PFA platforms still need to demonstrate long-term lesion durability, reproducibility and safety as use moves beyond pulmonary veins and into more complex arrhythmias.

The disruption may instead occur through a change in the default workflow. For common atrial fibrillation procedures, PFA could increasingly become the first energy modality physicians consider, with radiofrequency retained where its precision or lesion characteristics are advantageous.

That would still represent a profound change in cardiovascular-device economics. The companies competing successfully will not simply sell the catheter delivering the strongest electrical pulse. They will control increasingly integrated systems combining mapping, imaging, navigation, energy delivery, procedural software and reusable capital equipment.

The first breakthrough was proving that cardiac tissue could be ablated effectively without relying primarily on heat or freezing. The next battle is deciding which platform can turn electric-field ablation into the most reproducible operating system for the electrophysiology lab.