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Volt PFA System

Volt
Clinical Evidence

ReVolt Against the Ordinary

Reengineering PFA with the fewest applications1 and total control

Volt™ PFA System simplifies therapy delivery, minimizing procedural burden so you can treat more patients with ease and precision.1*

Simplicity by design



Delivers targeted lesion sets where it matters with an 8-spline balloon-in-basket design that conforms to anatomy and creates a wide-band lesion2 for fewer repositions

Volt PFA Tip
eField



Gain real-time procedural insight with elegant impedance-based contact visualization through AutoMark and eField integration for precise lesion tracking3,4

Three handling options for optimal positioning

Bi-Directional
Bi-Directional
Over-the-wire

Ensures ease of use and adaptability with an intuitive generator – designed for now and the future

Control at your fingertips

Current™ PFA Generator’s waveforms are designed to minimize microbubbles5 and patient movement for stability during energy delivery2

The only standalone generator with an integrated tissue contact display – empowering contact-guided energy applications, with or without a mapping system4

Features distal and proximal magnetic sensors for seamless EnSite™ X EP System integration

Eliminates the need for general anesthesia through light sedation compatibility6

CE Mark Sub-Analysis

PVI with Volt™ PFA Catheter, Sensor Enabled™ in subjects under deep or conscious sedation (CS/DS) does not significantly impact safety or acute outcomes compared to procedures with general anesthesia (GA).6

procedural characteristics
25-104836_EHRA_25_VOLT-1_E_r1a
Volt PFA acute effectiveness
25-104836_EHRA_25_VOLT-1_E_r1a

Unmatched performance with minimal applications

Create PVI with as few as two applications per vein1

2

The lowest number of applications of any PFA tool1 minimizing catheter repositions and increasing procedural efficiency1
 

Volt Pulse PFA System patient applications

*Based on published data from multicenter experience and separate studies, which may involve different patient populations and other variables. Not a head-to-head comparison. Data presented for informational purposes only.




Customize therapy for anatomic and patient variation by selectively delivering energy from electrodes in good contact

Livepoint Display
Single-catheter workflow






Enable a single-catheter workflow for mapping, pacing and ablating, minimizing catheter exchanges

Treat more patients safely

CE Mark 6-Month Results

Data from the Volt CE Mark study demonstrates that PVI with the Volt™ PFA System is both safe and effective for treating PAF and PsAF over a 6-month follow-up period.10

Volt PFA 6 month effectiveness
25-104837_EHRA_25_VOLT-2_E_r1a
PAF - PsAF

subjects free from documented AF/AFL/AT recurrence at 6-months

  • Durably Isolated PVs: The repeat ablation rate in the CE Mark cohort was only 1 in 20 patients (4.8%, n=7/146). In repeat ablations after the blanking period, 93.3% of veins were durably isolated10
  • Primary Safety Endpoint: 2.7% of subjects experienced a primary safety endpoint event10
    • 0% of subjects reporting hemolysis, acute kidney injury, phrenic nerve injury10

Reduces hemolysis11,12 by directly targeting tissue, avoiding the blood pool, and removing the need for additional fluid11

Threshold for clinically relevant hemolysis
0%

Hemolysis or kidney injury reported1
ReVolt Against the Ordinary with the PFA system engineered for extraordinary performance.
Manuals & Resources

Manuals & Resources

Cardiovascular Products

Cardiovascular Products

Customer Service

Customer Service

This device is commercially available for use in select international markets.

* Faster procedures allows us to treat more patients.
** In listed CE Mark or IDE trials for achievement of PVI.
*** Per protocol definition of isolation defined by entrance block after 20-minute wait period. 1 subject did not complete 20 minute wait period. 1 vein in 1 subject was not isolated after maximum allowed applications.
 

References

  1. Tilz, R.R. (2025, January 17) Acute results demonstrate safety and effectiveness of balloon-based pulsed field ablation system for de novo PVI in PAF and PersAF [Late Breaking Presentation]. AF Symposium 2025, Boston MA, USA.
  2. Data on file 90985059.
  3. Data on file 91057904.
  4. Data on file 91104530.
  5. Data on file 90985036.
  6. Acute safety and procedural characteristics of conscious and deep sedation to general anesthesia workflows with novel balloon-based PFA system (Oral presentation and abstract by Roland Tilz, EHRA 2025)
  7. Reddy VY, Gerstenfeld EP, Natale A, et al. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. NEngl J Med. 2023;389:1660-71. doi:10.1056/NEJMoa2307291.
  8. Verma A, Haines DE, Boersma LV, et al. Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial. Circulation. 2023;151(14):1433-1445. doi:10.1161/CIRCULATIONAHA.123.063988.
  9. Reddy VY, Calkins H, Mansour M, et al. Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial. Circulation. 2024;151(0). doi:10.1161/CIRCULATIONAHA.124.070333.
  10. Late Breaker presentation at EHRA 2025. Safety and Effectiveness of balloon-based PFA system for de novo PVI to treat PAF and PersAF: 6-Month Results of the Volt CE Mark Study (Tilz et al).
  11. Marcon L, Della Rocca DG, Vetta G, et al. Hemolysis Biomarkers After Pulmonary Vein Isolation via a Balloon-In-Basket PFA Catheter. Circulation. Online Version of Record before inclusion in an issue. doi:10.1161/CIRCULATIONAHA.124.070333.
  12. Overmann JA, Marques M, Lafean C, Pipenhagen C, Moon BL, Verma A. Hemolysis Profile of a Novel Balloon-Filled Basket Pulsed Field Ablation Catheter. Poster presented at: AF Symposium 2025; 2025 Jan 15-17; Boston, MA.

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