FDA signs off on study of Medtronic PFA system for atrial fibrillation

The FDA has notified Medtronic (MDT -0.3%) that it may proceed with a clinical trial ev

https://seekingalpha.com/news/3533983-fda-signs-off-on-study-of-medtronic-pfa-system-for-atrial-fibrillationaluating its PulseSelect Pulsed Field Ablation (PFA) System for the potential treatment of atrial fibrillation (AF).

In September 2018, the FDA granted Breakthrough Device designation for the investigational PFA technology for the treatment of drug-refractory recurrent symptomatic AF.

PFA uses pulsed electric fields to ablate or create lesions and scar tissue to interrupt irregular electrical pathways in the heart and the triggers of AF. PFA is non-thermal and selectively targets cardiomyocytes (heart muscle cells) while avoiding other types of tissue.