FDA approval for PulseSelect Pulsed Field Ablation (PFA) system for the treatment of both paroxysmal and persistent atrial fibrillation – Medtronic

Medtronic plc announced that the FDA has approved the PulseSelect Pulsed Field Ablation (PFA) System for the treatment of both paroxysmal and persistent atrial fibrillation (AF). This is the first PFA technology to receive FDA approval and follows the recent European CE (Conformité Européenne) Mark of the PulseSelect PFA system in November.

The PulseSelect PFA system was engineered with differentiated safety features and provides rapid, effective pulmonary vein isolation (PVI) through consistent and predictable energy delivery and catheter maneuverability. The system is designed to enable a seamless transition to PFA in a clinician’s preferred workflow . The PulseSelect PFA system’s safety, efficacy, and efficiency is supported by the PULSED AF study, which showed a 0.7% safety event rate and clinical success rates of 80% in both paroxysmal and persistent AF patients.

“The PulseSelect PFA system ushers the EP community to a new era of safe, effective, and efficient AF ablation that overcomes many challenges in our current practice,” said Dr. Amin Al-Ahmad, clinical cardiac electrophysiologist at St. David’s Medical Center in Austin, TX and one of 67 global operators in the PULSED AF trial. “In my clinical experience with the catheter, it was designed for AF ablation procedures. The learning curve in using the catheter and system is short, and the catheter enables the operator to deliver fast and controlled pulsed field energy for AF ablation.”

The PulseSelect PFA system also includes the following : i. Designed as a plug-and-play system, PulseSelect can be used with any mapping system or with just fluoroscopy. ii. Built-in safety features such as a phrenic nerve test pulse, a non-therapeutic low voltage pulse that provides a preemptive assessment of catheter proximity to the phrenic nerve prior to delivering a therapeutic application. iii. Fixed spacing for the nine-electrode catheter, which produces a predictable and consistent electric field for contiguous ablation. In addition to ablation, the nine electrodes can also be used for pacing and sensing. iv. The small, 9Fr bidirectional catheter enhances maneuverability and access to various anatomical structures and is compatible with a 10Fr sheath, including the custom bidirectional FlexCath Contour sheath.

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

About Atrial Fibrillation and Pulsed Field Ablation : AF is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. AF is a progressive disease, meaning it can become worse over time and can increase the risk of serious complications including heart failure, stroke and increased risk of death. Current ablation technologies rely on thermal effects to target cardiac tissue and risk damage to additional collateral structures in the heart. PFA is a breakthrough ablation technology that uses pulsed electric fields to efficiently isolate the pulmonary veins for the treatment of AF. Because the mechanism of cell death is non-thermal, the risk of collateral structure damage is potentially lower.