Medtronic's PulseSelect Pulsed Field Ablation System for the treatment of both paroxysmal and persistent atrial fibrillation has become the first PFA device to earn FDA approval.
"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," Rebecca Seidel, senior vice president and president of the Cardiac Ablation Solutions business, said in a Dec. 13 press release.
The system provides rapid, effective pulmonary vein isolation 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.
A study of the system showed a 0.7% safety event rate and clinical success rates of 80% in both paroxysmal and persistent Afib patients.
The system is designed as a plug-and-play system; has built-in safety features and fixed spacing for the nine-electrode catheter; and offers easy maneuverability.
Commercialization of the system will begin in early 2024.