Medtronic's PulseSelect PFA System Gets FDA Nod, Revolutionizing Atrial Fibrillation Treatment in US

The FDA approved Medtronic plc's MDT PulseSelect Pulsed Field Ablation (PFA) System for the treatment of both paroxysmal and persistent atrial fibrillation (AF), an irregular and often very rapid heart rhythm.

PulseSelect is the first PFA technology approved for use in the U.S. and the first PFA technology with FDA breakthrough designation to win approval following the recent European CE Mark of the PulseSelect PFA system in November.

Last Month, the FDA approved Medtronic's Symplicity Spyral renal denervation system, also known as the Symplicity blood pressure procedure, for hypertension or high blood pressure. 

Also Read: Medtronic's Q2 Earnings Beat Street View On Strong Surgical, Diabetes Devices, Lifts Annual Forecasts.

Pulsed-field ablation is a non-thermal method for cardiac ablation to treat AFib, delivering energy for pulmonary vein isolation while reducing the risk of damage to surrounding structures.  

Medtronic said its PULSED AF study demonstrated clinical success rates of 80% in both paroxysmal and persistent AFib patients, with only a 0.7% safety event rate.

The nine electrodes on the Medtronic PulseSelect system's catheter generate an electric field for contiguous ablation. Those electrodes can also be used for pacing and sensing.

PulseSelect is designed as a plug-and-play system for use with fluoroscopy only or any mapping system.

Commercialization of the PulseSelect PFA system will start in early 2024.

Price Action: MDT shares are up 1.20% at $82.88 during the premarket session on the last check Thursday.