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Pulsed Field Ablation (PFA)

Volt

Volt™ PFA System is commercially available in Europe.
CAUTION – This product is limited by U.S. Federal Law to investigational use. Product is not approved globally and may not be available in your market.

Volt™ PFA System

The Volt™ PFA System consists of the following components:

  • Volt™ PFA Catheter, Sensor Enabled™: A novel balloon-filled basket with 8 active splines. It is designed for therapy delivery, pacing, and the collection of electrical and anatomical data when used with the EnSite™ X EP System.
  • Current™ PFA Generator: The streamlined user interface includes waveform selection, tissue proximity LivePoint™ display, electrode selectivity, and therapy count tracking. Abbott's Current PFA Generator is designed for intuitive use and is built to be extensible for future PFA catheter types.
  • Agilis™ NxT Steerable Introducer, Dual Reach™ (13 F): The best-in-class Agilis™ platform now in a 13 F inner diameter for use with larger French size catheters. In addition, the Volt PFA catheter is compatible with a 13 F inner diameter introducer such as Agilis NxT Steerable Introducer. Visit the product page.

Volt PFA System Clinical Studies

Volt CE Mark Study

Before being used with patients, the Volt PFA System underwent extensive laboratory testing. Following this, the Volt CE Mark Study was the first clinical research study to investigate the Volt PFA System's safety and performance in treating human patients. The purpose of this study was to gather data demonstrating that the Volt PFA System functions as intended in a clinical setting and to establish its safety and effectiveness for treating atrial fibrillation.
 

Volt PFA product

CE Mark 12-Month Results1

VOLT CE Mark Study: Long-term safety and effectiveness of de novo PVI in treating AF. 

Protocol required PVI only left atrial ablation with the Volt™ PFA System

Effectiveness

of PAF (n=103) subjects free from documented AF/AFL/AT recurrence at 12-months1

83.5%
Volt PFA 12 month effectiveness

Repeat ablation and durably isolated PVs1

94.5% freedom from repeat ablation (5.5%, n=138/146)

90.0% of veins were durably isolated in repeat ablations after the blanking period

Primary safety endpoint

  • 0% of subjects reporting hemolysis, acute kidney injury, phrenic nerve injury1
  •  2.7% of subjects experienced a primary safety endpoint event1

58.1% of PersAF (n=43) subjects free from documented AF/AFL/AT recurrence at 12-months1

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.2,3

EP Volt workflows

VOLT-AF IDE and VOLT CE Mark Analyses

In multiple analyses, no clinically relevant hemolysis was observed, and biomarkers did not exhibit statistically significant change4-6

0%

Hemolysis or kidney injury reported in either VOLT-AF IDE or VOLT CE Mark studies6,7

VOLT-AF IDE Analysis

Threshold for clinically relevant hemolysis

CE Mark Feasibility Sub-Study Results

In the Volt CE Mark feasibility sub-study, acute effectiveness was achieved in 99.2% (127/128) of treated PVs (96.9% of subjects, 31/32) with 23.8 ± 4.2 PFA applications/subject. No esophegeal lesions causally related to Volt™ PFA System.

 

Volt AF IDE Study

This clinical research study is intended to demonstrate safety and effectiveness of the Volt™ PFA System for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.

Clinical Sub-Analysis Publication

Pre-Clinical Abstracts

Computer Modeling of PFA Waveform Design

2024 Manuscript Assessing PFA Design Considerations

Comparison of efficiency of PFA catheter designs by computer modeling. Computer models demonstrate a wide range in efficiency among PFA catheters. Form factors such as exposure of PFA electrodes to blood pool significantly influence efficiency. Higher efficiency designs, such as balloon-based designs, have less collateral current.

PFA clinical image
 
  1. 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.
  2. 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).
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. Hemolysis Biomarkers After Pulmonary Vein Isolation via a Balloon-In- Basket PFA Catheter. https://doi.org/10.1111/jce.16608.

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