PulseSelect is the first PFA technology approved for use in the U.S., as well as the first PFA technology with FDA breakthrough designation to win approval.
The minimally invasive, cardiac ablation system is indicated for the treatment of paroxysmal and persistent atrial fibrillation (AFIb).
Medtronic said it will start commercialization in early 2024.
“Launching the first FDA-approved PFA technology is not just a milestone; the PulseSelect PFA system is setting a new standard in safety for AF ablation with excellent efficacy and efficiency,” Medtronic SVP and Cardiac Ablation Solutions President Rebecca Se…