The United States Food and Drug Administration (FDA) has approved Medtronic’s PulseSelect pulsed field ablation (PFA) system for the treatment of both paroxysmal and persistent atrial fibrillation (AFib).
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, according to a release from Medtronic.
The PulseSelect PFA system was engineered with differentiated safety features and provides rapid, effective pulmonary vein isolation through consistent and predictable energy delivery and catheter maneuverability, according to a release from Medtronic. The PulseSelect PFA system’s safety, efficacy, and efficiency are 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 AFib patients.
“Launching the first FDA-approved PFA technology is not just a milestone; the PulseSelect PFA system is setting a new standard in safety for [AFib] ablation with excellent efficacy and efficiency. It’s a major step towards fulfilling our vision of providing disruptive electrophysiology solutions for patients,” says Rebecca Seidel, senior vice president and president of the cardiac ablation solutions business, part of the cardiovascular portfolio, at Medtronic, in a release.
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 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.
Photo caption: PulseSelect PFS system
Photo credit: Medtronic