Medtronic’s PulseSelect Becomes First FDA-Approved PFA System

The AFib pulsed field ablation treatment era officially began in the US last week, following the FDA approval of Medtronic’s PulseSelect Pulsed Field Ablation System for the treatment of both paroxysmal and persistent atrial fibrillation. 

  • PFA systems use electroporation (short electrical pulses) to achieve pulmonary vein isolation.
  • PFA is seen as safer and faster than current thermal ablation techniques, reducing damage to surrounding tissues and improving procedural efficiency.
  • The PulseSelect gained CE Mark approval in November, and will launch commercially in early 2024.

Medtronic was understandably celebratory in its PulseSelect lunch announcement, highlighting how it sets “a new standard in safety for AF ablation with excellent efficacy and efficiency.”

  • To back those statements up, Medtronic reminded us that the PulseSelect had a 0.7% safety event rate and 80% clinical success rate in the PULSED AF study.
  • At 1 year, the PulseSelect PFA was also clinically effective among 66.2% of patients with paroxysmal AF and 55.1% of patients with persistent AF (both above the 50% target).

Medtronic also emphasized the PulseSelect’s role in the company’s overall AFib ablation lineup, which includes its current cryoablation portfolio, and its PulseSelect-compatible Affera mapping system (currently CE Marked).

The PulseSelect might be the US’ first PFA system, but more are likely on the way, including later-stage systems from Boston Scientific (CE Marked, FDA expected in 2024) and ablation giant Biosense Webster. Abbott meanwhile has an earlier-stage system, but is taking a “wait-and-see” approach to the PFA segment.

The Takeaway
The pulsed field ablation era is now upon us, and although not everyone is convinced it will be a game-changer, many believe it could have a major impact on how AFib ablations are performed. If that proves true, it would also have a major impact on the $7B-$9B AFib ablation segment, while likely benefiting the PFA first-movers like Medtronic.

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