Medtronic: PulseSelect PFA system approved by FDA

(CercleFinance.com) - Medtronic announced on Wednesday evening that its PulseSelect pulsed field ablation (PFA) system for the treatment of paroxysmal and persistent atrial fibrillation (AF) has been approved by the US FDA.


This is the first PFA technology to receive FDA approval, and follows the recent European CE (Conformité Européenne) marking of the PulseSelect PFA system in November, the medical equipment supplier points out.

The safety, efficacy and efficiency of the PulseSelect PFA system are supported by the PULSED AF study, which showed a safety event rate of 0.7% and clinical success rates of 80%. Its marketing will begin in early 2024.


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