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
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
Ensures ease of use and adaptability with an intuitive generator – designed for now and the future
Current™ PFA Generator is 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
VOLT-AF IDE and VOLT CE Mark Studies
Subjects under conscious sedation (CS) and deep sedation (DS) workflows experienced acute effectiveness with no significant difference in safety when compared to general anesthesia (GA) procedures.6,14
Unmatched performance with minimal applications
Create PVI with as few as two applications per vein1
The lowest number of applications of any PFA tool1 minimizing catheter repositions and increasing procedural efficiency1
*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
Enable a single-catheter workflow for mapping, pacing and ablating, minimizing catheter exchanges
Treat more patients safely
CE Mark 12-Month Results10
Protocol required PVI only left atrial ablation with the Volt™ PFA System
Effectiveness
Repeat ablation and durably isolated PVs
83.5%
of PAF (n=103) subjects free from documented AF/AFL/AT recurrence at 12-months
94.5%
90.0%
freedom from repeat ablation (5.5%, n=138/146)
of veins were durably isolated in repeat ablations after the blanking period
Primary safety endpoint10
0%
of subjects reporting hemolysis, acute kidney injury, phrenic nerve injury
2.7% of subjects experienced a primary safety endpoint event
58.1% of PersAF (n=43) subjects free from documented AF/AFL/AT recurrence at 12-months
In multiple analyses, no clinically relevant hemolysis was observed, and biomarkers did not exhibit statistically significant change.11-13
Volt PFA System directly targets tissue, avoiding the blood pool, and removes the need for additional fluid.11
Hemolysis or kidney injury reported in either VOLT-AF IDE or VOLT CE Mark studies1,13
VOLT-AF IDE Analysis
No periprocedural hydration protocol performed
Applications per patient: 17.7 ± 3.8 PFA applications/subject
Non-significant changes in hemolysis biomarkers and renal function in 157 subjects across 27 sites13
Volt is commercially available in Europe.
Caution - This product is limited by US Federal law to investigational use. Product is not approved globally.
* Faster procedures allows us to treat more patients.
** In listed CE Mark or IDE trials for acheivement of PVI.
† 4 veins in 1 subject did not have assessment after 20 min wait period.
References
- 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.
- Data on file 90985059.
- Data on file 91057904.
- Data on file 91104530.
- Data on file 90985036.
- 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)
- 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.
- 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.
- 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.
- Tilz, R., et al. (2025, April 26). Long-Term Safety and Effectiveness of balloon-based PFA system for de novo PVI to treat PAF and PersAF: Results from the VOLT CE Mark Study [Oral presentation]. Presented by Prash Sanders. Heart Rhythm Society 2025, San Diego, CA.
- 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.
- 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.
- Woods, C., et al. (2025, April 26). Impact of pulsed field ablation using a balloon-in-basket catheter on hemolysis and renal function biomarkers [Poster presentation]. Heart Rhythm Society 2025, San Diego, CA.
- Lo, M., et al. (2025, April 26). Procedural efficiency, safety and acute effectiveness of conscious and deep sedation workflows with novel balloon-based PFA system [Poster presentation]. Heart Rhythm Society 2025, San Diego, CA.
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