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Pulsed Field Ablation (PFA)

Volt

Volt™ PFA System

The Volt™ PFA System is investigational and not approved for sale in any geography. It 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 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 diameter for use with larger French size catheters. In addition, the Volt PFA System works 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 to investigate the Volt PFA System's 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 Acute Results | Full Cohort

The Volt CE Mark trial acute results were presented by Prof. Roland Tilz at AF Symposium 2025 as a late beaker session.1
 

Effectiveness

99.1% Isolation by PV (n=573/578)
97.6% First-pass Isolation by PV (n=564/578)
98.6% Isolation by subject (n=144/146)


Safety

2.7% Primary SAE and 0% Hemolysis, Kidney Injury, Phrenic Injury, Coronary Spasm, Lesions, PV Stenosis


Procedural Information

 

100.4 Procedure time
17.6 PFA applications per patient
17.3 Fluoroscopy time


Demographics

11 Centers in AUS/EUR, 146 mean age 64.1±10 years 63% male, 70.5% Paroxysmal AF, 100% PVI Only HD Mapping


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.

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

The Volt PFA Catheter, Sensor Enabled and Current PFA Generator are investigational devices. LIMITED BY FEDERAL (OR U.S.) LAW TO INVESTIGATIONAL USE. These products are not available for sale in any geography.

For additional Safety Information: The Agilis™ NxT Steerable Introducer, Dual-Reach

* Four (4) veins in 1 subject did not complete 20 min wait period necessary to meet endpoint. One (1) vein was not isolated after max therapy applications
** Includes 20-minute waiting period, pre- and post-procedure phrenic nerve stimulation and voltage mapping
*** Minimum 2 application per vein required per protocol
1. Tilz, R.R. (2025, January 17) Acute results demonstrate safety and e4ectiveness of balloon-based pulsed field ablation system for de novo PVI in PAF and PersAF [Late Breaking Presentation]. AF Symposium 2025, Boston MA, USA. Available upon request until published by AF Symposium.

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CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

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