Abbott Volt PFA shows strong 12‑month efficacy, safety in global real‑world study

Volt PFA posts strong 12-month outcomes in global real‑world study

Abbott Laboratories is reporting 12‑month data from its multi‑center VOLT‑AF Global IDE study that reinforce the safety and efficacy of its Volt Pulsed Field Ablation (PFA) System for treating atrial fibrillation (AF). The single‑arm study, spanning roughly 40 centers across the United States, Europe, Canada and Australia, shows an industry‑leading 84.2% freedom from documented rhythm recurrence for paroxysmal AF and about 67.9% for persistent AF at one year. Physicians use an average of 4.6 applications per vein, and fewer than 6% of patients require repeat ablation, indicating a reduced procedural burden compared with many historical benchmarks.

Patient‑reported outcomes in the VOLT‑AF study demonstrate substantial quality‑of‑life gains on the AFEQT instrument, with scores improving from 63.6 to 91.4 for paroxysmal AF and from 64.2 to 91.4 for persistent AF. Safety signals are notable: the trial reports no complications related to esophageal injury or hemolysis at 12 months. Abbott emphasizes that the IDE study captures both objective rhythm outcomes and patient‑reported measures in a broad, routine‑practice population, underscoring the device’s performance outside highly controlled investigational settings.

Investigators and Abbott frame the results as evidence of durable clinical performance for Volt PFA, saying the combination of high freedom from recurrence, low repeat‑procedure rates and strong quality‑of‑life improvements position the technology as an effective, efficient option for electrophysiologists. The findings are presented at the AF Symposium in Boston and accompany a simultaneous publication in JACC: Clinical Electrophysiology, supporting ongoing clinical adoption and further evaluation.

TactiFlex Duo focal catheter shows clinical benefit

Separately, Abbott presents 12‑month results from the CE Mark FOCALFLEX trial for its dual‑energy, focal TactiFlex Duo Ablation Catheter, Sensor Enabled. The data highlight the catheter’s sensor‑enabled design that lets operators tailor energy delivery to patient anatomy and electrophysiology, demonstrating safety and efficacy in more complex AF cases and significant reductions in AF episodes.

Regulatory and clinical adoption outlook

Abbott says the combined VOLT‑AF and FOCALFLEX results support wider adoption, registry follow‑up and potential label expansions as regulatory reviews continue. The company is positioning continued investment in next‑generation ablation technologies as central to expanding treatment options for electrophysiologists managing AF.