Intended for healthcare professionals

Cardiovascular

Pulsed field ablation (PFA)​

We provide you with solutions for safe, effective ablation techniques that can be reproduced with confidence.


Adding Pulsed Field Ablation (PFA) to our existing Radiofrequency (RF) portfolio enables a patient-tailored approach for the treatment of AF. Fully-integrated mapping with the CARTO™ 3 System provides real-time

tissue to electrode feedback and lesion tagging which have proven to be important factors for durable lesion formation.1

View evidenceLearn about the VARIPULSE™ Platform
A clinician in surgical attire positions a catheter at the patient’s groin access site during a pulsed field ablation procedure. A large monitor displays a 3D anatomical model with purple ablation zones and catheter loop positioning, guiding real-time decision-making and lesion placement.

Evidence

A stylized, semi-abstract 3D model of a human heart shaded in gradients of purple and orange appears against a light gray background. The image visually represents VARIPURE, highlighting the strong safety profile of the VARIPULSE™ Platform.

VARIPURE

Zero serious adverse events were reported after ablation with the VARIPULSE™ Catheter, including zero neurovascular events.

Two images compare catheter–tissue contact effects. The left image shows a catheter loop with numbered electrodes, where some electrodes display Tissue Proximity Indicator (TPI) shading and others labeled “no TPI.” The right image shows a cross-section of tissue with a circled region demonstrating deeper lesion formation where electrode contact occurred. Together, the images illustrate that application repetition and catheter–tissue contact impact lesion depth in PFA delivery.

Application repetition and electrode–tissue contact with a VLCC

This study determined that lesion formation is dependent on application repetition and contact.  Both repetition and catheter contact independently lead to deeper lesion formation are critical for PFA delivery.

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A bar graph displays lesion transmurality percentages for three catheter–tissue contact conditions. “No/minimum contact” shows approximately 55% transmurality, while both “consistent contact” and “tissue tenting” show 100% transmurality. Statistical markers (P < .001) indicate significant differences between groups, demonstrating that stronger catheter–tissue contact results in more consistent lesion formation.

In vivo assessment of catheter-tissue contact

This preclinical study emphasizes the importance of tissue contact in optimizing circumferential lesion. PF ablation was applied to 5 swine with varying levels of contact as determined by ultrasound and the tissue proximity indicator (TPI). Lesion transmurality was achieved in all lesions with consistent contact or tissue tenting but only in 54.5% with no/minimum contact.

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A bar graph displays three patient-reported outcomes from the inspIRE deep sedation analysis. – 79% of patients reported being very satisfied with pain management. – 69% reported they do not remember having pain during the procedure. – 86% stated they would opt for the same treatment again for pain management. The data demonstrates high satisfaction and tolerability with deep sedation during VARIPULSE™ procedures.

inspIRE deep sedation analysis

29 participants in the insIRE study received sedation during pulse filed ablation procedure with the VARIPULSE catheter due to risks of general anesthesia. The deep sedation protocol, when used in conjunction with VARIPULSE™ platform, was safe and achieved positive feedback reported by patients.

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Two donut charts illustrate the admIRE subanalysis results. – The left chart, labeled “Full Cohort PEE,” shows a 75% primary efficacy endpoint. – The right chart, labeled “Optimized Cohort PEE,” shows an 85% primary efficacy endpoint for patients who received 24–32 ablations. Dashed lines visually link the charts, emphasizing improved efficacy with optimized ablation workflows.

admIRE subanalysis

 In a subanalysis of admIRE patients, it was noted that the full patient cohort primary efficacy endpoint (PEE) of 74.6%  increased to 85% for patients that received 73-96 applications (24-32 ablations).

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A bar graph displays PVI durability percentages under two conditions. – “Without Imaging” shows durability at approximately 35%. – “With Imaging” shows durability at approximately 47%. The comparison illustrates findings from the MANIFEST RE-DO study, showing that prior use of imaging or mapping modalities is associated with improved PVI durability.

MANIFEST RE-DO

MANIFEST RE-DO investigated repeat ablation due to clinical recurrence of AF or AT following treatment with the pentaspline PFA catheter, Farawave. In this repeat procedure, it was found 45% of patients where imaging or mapping modality was previously used was univariately associated with durable PVI.

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A stylized close-up image of an electrocardiogram-like waveform in red, displayed on a pink medical grid background. The visual serves as a thematic representation of cardiac electrical activity for the section discussing first experience with a novel VLCC in pulsed field ablation mapping.

First experience with a novel VLCC

This study utilized both the high-density mapping catheter and the VLCC in all patients. A high correlation between LA post-ablation remapping of low voltage areas and ablated regions was observed. The integration of the 3D mapping system allows for precise labeling of every PFA application and disabling location tags deactivated electrodes in the event of electrode overlapping. A high degree of precision was observed in the overlap of ablation tags and low voltage areas.

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A bar chart titled “Indicators of Hemolysis” shows two hemolysis markers comparing RFA Δ change (red bars) and PFA Δ change (gray bars). - For Lactate Dehydrogenase (IU/L), RFA shows a modest increase (~25 IU/L), while PFA shows a large increase (~105 IU/L). - For Plasma-Free Hemoglobin (mg/dL), RFA shows a small rise (~12 mg/dL), and PFA shows a substantially higher rise (~60 mg/dL). The chart demonstrates that PFA is associated with greater hemolysis changes than RFA.

NEMESIS

The NEMESIS study evaluated the collateral effects of PFA, including biomarkers that indicate hemolysis. The PFA group revealed greater red cell destruction compared to the RFA group because high-voltage electrical fields may have greater effect on circulating blood. This increased with the number of applications and continued contact with blood (not tissue).

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A clinician in full procedural attire—mask, gloves, and sterile gown—holds a flexible blue mapping catheter with an electrode loop at the tip. He observes a nearby monitor showing a 3D cardiac anatomy model used for catheter navigation and mapping during the procedure.
A clinician in full procedural attire—mask, gloves, and sterile gown—holds a flexible blue mapping catheter with an electrode loop at the tip. He observes a nearby monitor showing a 3D cardiac anatomy model used for catheter navigation and mapping during the procedure.

Part of an integrated system

As ablation energy sources evolve, the fully-integrated CARTO™ 3 System is the cornerstone of catheter ablation to enable accurate, real-time catheter visualization and empower you to make optimal, patient-tailored treatment decisions.*

Learn more about our CARTO-integrated portfolio
A high-resolution close-up of a spiral blue catheter loop with evenly spaced metal electrodes is shown coming from the right.
A high-resolution close-up of a spiral blue catheter loop with evenly spaced metal electrodes is shown coming from the right.

Intuitive. Versatile. Reproducible.

VARIPULSE™ Platform

Johnson & Johnson MedTech is bringing the first CARTO-integrated Pulse Field Ablation platform with the VARIPULSE™ Catheter, an intuitive pulmonary vein isolation solution powered by the TRUPULSE™ Generator.

Learn moreView admIRE study

Zero

strokes with VARIPULSE™ Platform in almost 1,000 patients across US & Europe2,3

85%

peak 12-month effectiveness with 73–96 PFA applications (24-32 ablations)

 *admIRE trial n=85. PAF only patients, 1 ablation = 3 applications

63.5%

of cases done with zero fluoroscopy3

30%

cases performed under conscious sedation5

Supporting with excellence

A clinician in glasses reviews a brightly colored 3D heart mapping visualization on a computer screen, with the reflection of the image visible in her lenses. A second clinician, partially visible, stands next to her as they analyze the data together.

Expertise at your side

Our team of clinical specialists have a deep knowledge in every aspect of the mapping technology to complement your team’s skills and offer real-time insights when you need them.

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Two surgeons wearing masks, gloves, and headsets work together during a procedure, guiding instruments over a draped patient. A monitor behind them displays detailed 3D cardiac mapping visuals and electrophysiology data.

Training Expertise Centers

We offer a comprehensive site visit program to physicians and fellows who are interested in observing safe and effective utilization of our current technology during complex ablations in a clinical setting.

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A male clinician in scrubs and a female clinician in a white coat walk together in a bright medical facility, smiling as they review information on a tablet. Both wear ID badges, and a plant-filled lobby is visible behind them.

Therapy Advancement Program

Through every step of your journey, our Therapy Advancement Program (TAP) empowers you with the resources, tools, and support to treat more AFib patients—while potentially increasing access to care.

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A clinician wearing blue gloves holds a detailed anatomical heart model and points to a section while a patient, seated with EKG electrodes on his chest, watches attentively during a cardiac evaluation.

Patient Education Resources

With a focus on clear and accessible AFib education, insights from physician thought leaders, and compelling patient stories, Get Smart About AFib aims to be a trusted resource where physicians and providers can confidently refer their patients.

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References

  1. Di Biase L, Marazzato J, Gomez T, et al. Application repetition and electrode–tissue contact result in deeper lesions using a pulsed-field ablation circular variable loop catheter. EP Europace. 2024;26(9):euae220.

  2. Almorad A, Sebag FA, Kronborg MB, et al. Acute Safety, Effectiveness and Procedural Workflow for the Pulsed Field Ablation Variable Loop Circular Catheter in AF Procedures: A Prospective, Multicenter, Postmarket Clinical Trial. Presented at ESC 2025; September 1, 2025; Madrid, Spain. Pending formal publication.
  3. Porterfield C. Real-world safety profile of a multi-electrode variable loop PFA catheter. Presented at KCHRS 2025; August 16, 2025; Kansas City, MO. Pending formal publication.
  4. Reddy V, Calkins H, Mansour M, et al. Pulsed field ablation to treat paroxysmal atrial fibrillation: safety and effectiveness in the admIRE pivotal trial. Circulation. Published online September 11, 2024. doi: 10.1161/CIRCULATIONAHA.124.070333.
  5. De Potter T, Grimaldi M, Duytschaever M, et al. Predictors of success for pulmonary vein isolation with pulsed field ablation using a variable loop catheter with 3D mapping integration: complete 12-month outcomes from inspIRE. Circ Arrhythm Electrophysiol. 2024. doi: 10.1161/CIRCEP.123.012667.

*Biosense Webster, Inc.’s products with FDA approved/cleared instructions for use to support fluoro alternative workflows when used with the CARTO™ 3 System include the following: THERMOCOOL SMARTTOUCH™ SF Catheter, THERMOCOOL SMARTTOUCH™ Catheter, VARIPULSE™ Catheter, CARTO™ VIZIGO™ Bi-Directional Guiding Sheath, PENTARAY™ NAV ECO High Density Mapping Catheter, OCTARAY™ Mapping Catheter with TRUEref™ Technology, OPTRELL™ Mapping Catheter with TRUEref™ Technology, DECANAV™ Mapping Catheters, and Webster™ CS Catheter.


Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions. Caution: US law restricts this device to sale by or on the order of a physician.


 Always verify catheter tip location using common clinical practice for real-time verification (inspection of IC signals, direct imaging guidance such as fluoroscopy or ultrasound, etc.) and consult the CARTO™ 3 System User Guide regarding recommendations for fluoroscopy use.


Canpolat, U. et al (2020). State of Fluoroless Procedures in Cardiac Electrophysiology Practice. J Innov Cardiac Rhythm Management. 11(3), 4018–4029.

Sommer, P. et al (2018) Safety profile of near-zero fluoroscopy atrial fibrillation ablation with non-fluoroscopic catheter visualization: experience from 1000 consecutive procedures, EP Europace, Volume 20, Issue 12, Pages 1952–1958.


The THERMOCOOL SMARTTOUCH™ SF Catheter is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (AF) and for drug refractory recurrent symptomatic persistent AF (continuous AF > 7 days but < 1 year), refractory or intolerant to at least 1 Class I or III AAD, when used with the CARTO™ 3 System.

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