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Abbott Gains CE Mark for Volt PFA System, Accelerates EU Launch
Abbott has received CE mark approval earlier than expected for its Volt pulsed field ablation (PFA) system to treat atrial fibrillation (AFib) and has begun commercial procedures in the European Union. The system aims to address limitations of first-generation PFA devices by improving visualization and reducing therapy applications, leading to better patient outcomes.
Abbott has lagged behind Boston Scientific, Medtronic, and Johnson & Johnson in launching a PFA device but now plans to accelerate its European rollout. The company completed U.S. patient enrollment four months early and expects FDA approval in 2026.
PFA uses electrical pulses to eliminate faulty heart cells, reducing risks compared to heat or cold-based ablation. In trials, Volt achieved pulmonary vein isolation in 99.1% of treated veins. Abbott is also developing next-gen PFA technology for more targeted heart lesion treatments.
02-04-2025