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Abbott Secures European CE Mark for Volt PFA System to Treat Atrial Fibrillation

Shots:

  • Abbott has received European CE Mark for its Volt PFA System to treat pts with atrial fibrillation; commercialization has begun, with further expansion in EU markets expected by H2’25
  • Approval was based on CE Mark study in the EU & Australia, showing that the Volt achieved pulmonary vein isolation (PVI) in 99.1% veins with fewer energy applications than other marketed PFA systems
  • Volt, integrated with Abbott’s EnSite X EP system, provides simplified workflow, efficient energy delivery via its balloon-in-basket design, plus procedural flexibility with sedation options & is being evaluated in the VOLT-AF IDE study, which completed early enrollment (n~400), with 12mos. follow-up expected in 2025

Ref: Prnewswire | Image: Abbott

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