Results included 12-month findings supporting the Volt pulsed field ablation (PFA) system and positive outcomes with the TactiFlex Duo Ablation Catheter, Sensor Enabled (SE).
Volt provides a single-catheter PFA approach to improve workflow and provide procedural flexibility. The company designed Volt to address the limitations of existing PFA technologies. With FDA clearance in December 2025, the company entered the hot PFA space, competing against Medtronic, Boston Scientific, Johnson & Johnson MedTech and Kardium.
TactiFlex Duo, a dual-energy, focal ablation catheter, enables physicians to tailor how they deliver AFib therapy. Its radiofrequency energy capabilities use heat to destroy tissue responsible for erratic heart signals. The pulsed field function uses high-energy electrical pulses to destroy the cells causing abnormal heart rhythms. The CE-marked catheter also has FDA breakthrough device designation for the treatment of ventricular tachycardia (VT). It could rival J&J MedTech’s ThermoCool dual-ablation catheter.
Abbott shared its findings for both catheter systems at the AF Symposium in Boston.
A look at the results from Abbott
Volt demonstrates sustained performance
The VOLT-AF global IDE study was conducted across approximately 40 centers in the U.S., Europe, Canada and Australia.
Abbott said that 12-month data from the study found that Volt delivered an “industry-leading” success rate (84.2%) of freedom from documented rhythm recurrence among all competitive PFA products to treat paroxysmal AFib episodes (episodes that come and go).
In the study, Volt also delivered strong results as a treatment option for AFib episodes that last longer than seven days (persistent AFib). Nearly 68% of patients remained free from an additional episode following a Volt ablation procedure.
Additional findings included fewer therapy applications (4.6 per vein on average) compared to other on-market PFA systems. The trial found that less than 6% of patients required a repeat ablation. Patients also reported a significant improvement in a quality of life self-assessment.
Volt also delivered a strong safety profile, with zero patient complications related to either an unintended injury to the esophagus, or the breakdown of red blood cells (hemolysis). This can cause sudden kidney damage.
“The data for Volt confirms what I see firsthand in the procedure room with this next-generation PFA device,” said Dr. Atul Verma, director of the Division of Cardiology at McGill University Health Centre and McGill University in Montreal, Canada, who treated patients as part of the VOLT-AF IDE study and presented the late-breaking data at AF Symposium. “The system’s unique design enables a high degree of freedom from AFib for patients, and its impressive safety profile reduces PFA-specific complications such as hemolysis, which negatively impacts other parts of the body.”
TactiFlex Duo shows safety and effectiveness
Abbott also shared six-month data from the FOCALFLEX global CE mark trial. Findings confirmed the TactiFlex Duo’s safety and effectiveness in more complex AFib cases.
The study demonstrated a clinically meaningful success rate (81%) of freedom from documented rhythm recurrence among persistent AFib patients. Self-reported quality of life scores also rose in the data, which came from more than 20 centers in Europe, the UK and Australia. Findings contributed to the system’s recent CE mark approval.
In addition to the CE mark study, Abbott also completed enrollment for the FLEXPULSE global IDE trial to evaluate TactiFlex Duo in AFib. It holds FDA breakthrough device designation for treating ventricular tachycardia (VT) as well.
“With the rising rates of AFib around the world, data from the Volt PFA and TactiFlex Duo trials help empower physicians with further confidence in using these devices to treat people with AFib – from the recently diagnosed to the most complex cases,” said Dr. Christopher Piorkowski, chief medical officer of Abbott’s electrophysiology business. “These studies help solidify our treatment offerings for AFib as we strive to challenge the status quo to develop even better tools that physicians can rely on to care for their patients.”
