Medtronic’s novel PulseSelect Pulsed Field Ablation System to treat atrial fibrillation is first PFA to receive FDA approval

Medtronic has received US FDA approval for 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 European CE Mark approval for the PulseSelect PFA system in November.

“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. It’s a major step towards fulfilling our vision of providing disruptive electrophysiology solutions for patients,” said Rebecca Seidel, SVP and President of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio. “The PulseSelect PFA system, together with the CE Marked Affera mapping and ablation system and our strong Cryo platform, enables us to provide a broad portfolio of solutions to clinicians and their patients, all developed with years of research and supported by compelling scientific evidence.”

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 manoeuvrability. 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 electrophysiology 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.

The PulseSelect PFA system also includes the following:
• Designed as a plug-and-play system, PulseSelect can be used with any mapping system or with just fluoroscopy.
• 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.
• 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.
• The small, 9Fr bidirectional catheter enhances manoeuvrability and access to various anatomical structures and is compatible with a 10Fr sheath, including the custom bidirectional FlexCath Contour sheath.

The PulseSelect PFA system is also the first FDA Breakthrough-designated PFA technology to be approved. The designation is intended to help patients gain more timely access to medical devices that have the potential to make a significant impact in the diagnosis or treatment of life-threatening conditions.

Commercialization of the PulseSelect PFA system is expected to start early this year.

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