Breaking: New Data for Abbott PFA Tools

New data from the VOLT-AF IDE Study describe the use of a balloon‑in‑basket pulsed field ablation system for patients with PAF and PersAF. The study reports on procedural characteristics, patient outcomes, and measures of quality of life. The platform has been designed as an option for de novo PVI.

12-month IDE results evaluate safety and effectiveness

1.9%

Primary Safety Endpoint

5.9%

Repeat ablation rate (19/320 patients)

78.5%

Durable isolation of PVs among patients who required repeat ablation

12-month freedom from documented arrhythmia recurrence

84.2%

PAF

67.8%

PersAF

These results reinforce the Volt PFA System’s ability to deliver safe, effective, and lasting outcomes—helping clinicians treat confidently while supporting long term patient wellbeing.

New: 6-month data evaluated the safety and effectivess in a range of conditions

TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ is CE Marked and available for sale in EUROPE. Caution: investigational device. Limited by Federal (or United States) law to investigational use.

Recent results from the FOCALFLEX Study describe the use of the TactiFlex Duo System in pulsed field ablation procedures and outline observations related to safety data and ablation approaches evaluated in the study.

Six month findings evaluate strong clinical performance across multiple dimensions:

1.4%

Primary Safety Endpoint (2/147)

81%

of patients remained free from documented arrhythmia recurrence at 6 months

1

Repeat ablation (1/144) after the blanking period

Lesion strategy distribution

79.2%

treated with PF-only lesions

20.1%

treated with combined PF + RF

Duo catheter used beyond the PVs in 20.8% of patients, including:

CTI line (18/144); Posterior wall (12/144); Roof line (9/144)

Quality of life improvements:

AF Effect on Quality of Life (AFEQT) overall score: +22.0

EQ-5D-5L Visual Analog Score (VAS): +6.6

1. Verma, A., et al. (2026, February 5) 12-Month Safety and Effectiveness of a balloon-in-basket PFA system for de novo PVI to treat PAF and PersAF: Results from the VOLT-AF IDE Study [Late Breaking Presentation]. AF Symposium 2026, Boston MA, USA.

2. Silberbauer, J., et al. (2026, February 5) Safety and Effectiveness of the TactiFlex Duo System: 6-Month Results of the FOCALFLEX Study [Late Breaking Presentation]. AF Symposium 2026, Boston MA, USA.