Before being used with patients, the Volt PFA System underwent extensive laboratory testing. Following this, the 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.
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.
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.
Chronic Safety and Efficacy of a Novel Balloon Basket PFA Catheter in a Canine Model with Multi-Level Dosing. PVI using PFA with or without 3D mapping system resulted in a similar acute outcome and safety profile. Procedure times were significantly shorter in the fluoroscopy only group. There were no PFA-specific complications. Abstract Number: AB-885-AT
Tissue contact is important for an effective pulsed field ablation: Evidence from preclinical in-vitro and in-vivo studies. This reasearch demonstrates the importance of tissue contact (LivePoint™ Display) in achieving successful chronic PVI. Abstract Number: AB-749-AT
Chronic Safety and Efficacy of a Novel Basket PFA Catheter in a Swine Model. We report on first animal data from a Novel PFA Catheter in a chronic Swine Model.
Chronic Safety and Efficacy of a Novel Balloon Basket PFA Catheter in a Canine Model with Multi-Level Dosing. Investigate the safety and efficacy of PFA therapy using a novel, balloon-based catheter in a chronic canine model.
Hemolysis Profile of a Novel Balloon-Filled Basket Pulsed Field Ablation Catheter. No acute complications were observed during PFA application, and all six canines survived until termination. As presented at AF Symposium 2025.
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
MAT-2415464 v2.0
Stay Connected