Abbott's Ablation Catheters Showcase Safety and Efficacy in Treating Atrial Fibrillation

New data from VOLT-AF and FOCALFLEX studies demonstrate strong performance of Volt PFA System and TactiFlex Duo Ablation Catheter

Published on Feb. 8, 2026

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Abbott announced positive results from two late-breaking presentations at the AF Symposium that demonstrate the safety and efficacy of its minimally invasive therapies to treat atrial fibrillation (AFib). The 12-month data from the VOLT-AF Global IDE study found the Volt Pulsed Field Ablation (PFA) System had an industry-leading success rate, while the FOCALFLEX CE Mark trial confirmed the safety and effectiveness of the TactiFlex Duo Ablation Catheter, Sensor Enabled.

Why it matters

These findings reinforce Abbott's position as a leader in developing innovative treatments for AFib, a common and potentially serious heart rhythm disorder that affects millions of people worldwide. The data showcases the company's commitment to advancing minimally invasive therapies that can improve outcomes and quality of life for patients.

The details

The VOLT-AF study found the Volt PFA System had an 84.2% success rate in treating paroxysmal AFib and nearly 68% success in treating persistent AFib. Patients also reported significant improvements in quality of life. The FOCALFLEX trial demonstrated an 81% success rate in treating paroxysmal AFib with the TactiFlex Duo Ablation Catheter, which uses dual-energy technology to allow physicians to tailor therapy delivery.

  • The VOLT-AF IDE study results were presented at the AF Symposium on February 5, 2026 and simultaneously published in JACC: Clinical Electrophysiology.
  • The FOCALFLEX CE Mark trial data was presented at the AF Symposium on February 5, 2026.

The players

Abbott

A global healthcare leader that develops life-changing technologies across diagnostics, medical devices, nutritionals, and branded generic medicines.

Atul Verma, M.D.

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.

Christopher Piorkowski, M.D.

Chief medical officer of Abbott's electrophysiology business.

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What they’re saying

“The data for Volt confirms what I see firsthand in the procedure room with this next-generation PFA device. 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.”

— Atul Verma, M.D., Director of the Division of Cardiology at McGill University Health Centre and McGill University (JACC: Clinical Electrophysiology)

“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. 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.”

— Christopher Piorkowski, M.D., Chief Medical Officer of Abbott's Electrophysiology Business (JACC: Clinical Electrophysiology)

What’s next

Abbott plans to continue expanding the commercial availability of the Volt PFA System in the U.S. and Europe. The company also recently completed enrollment for the FLEXPULSE Global IDE trial to evaluate the TactiFlex Duo Ablation Catheter, and the FDA has granted Breakthrough Device Designation for using the TactiFlex Duo to treat Ventricular Tachycardia.

The takeaway

The positive results from the VOLT-AF and FOCALFLEX studies demonstrate Abbott's commitment to developing innovative, minimally invasive therapies that can improve outcomes and quality of life for patients with atrial fibrillation. These findings reinforce the company's position as a leader in the electrophysiology space and provide physicians with greater confidence in using these advanced technologies to treat a wide range of AFib cases.