Medtronic has received approval from the US Food and Drug Administration (FDA) for its PulseSelect pulsed field ablation (PFA) system to treat both paroxysmal and persistent atrial fibrillation (AF).
Last month, the company obtained the European Conformité Européenne (CE) mark for the system.
It is designed with differentiated safety features and delivers rapid pulmonary vein isolation (PVI) through consistent and predictable energy delivery, coupled with catheter manoeuvrability.
The PULSED AF study demonstrated the efficacy, efficiency and safety of the system with a 0.7% safety event rate and 80% clinical success rates in both paroxysmal and persistent AF patients.
PulseSelect is designed as a plug-and-play system and is compatible with any mapping system or fluoroscopy alone.
It comes with safety features such as a phrenic nerve test pulse and a non-therapeutic low-voltage signal, which offers a preemptive assessment of catheter proximity to the phrenic nerve before delivering any therapeutic application.
The system also provides fixed spacing for the nine-electrode catheter that generates a predictable and consistent electric field for contiguous ablation.
Furthermore, the nine electrodes are suitable for pacing and sensing.
The small, 9Fr bidirectional catheter improves manoeuvrability and access to several anatomical structures. It is also compatible with a 10Fr sheath, including the custom bidirectional FlexCath Contour sheath.
Medtronic Cardiac Ablation Solutions business chief medical officer Khaldoun Tarakji said: “We are thrilled to see the continuous innovation of our legacy Cryoablation portfolio alongside the approval of the PulseSelect PFA system in the US.”
The PulseSelect PFA system will be available for commercial use beginning early next year. It is also claimed to be the first PFA technology to receive breakthrough designation from the FDA.
Last month, the company obtained approval from the FDA for its Symplicity Spyral renal denervation system to treat hypertension.
The minimally invasive procedure is intended for delivering radiofrequency energy to nerves near the kidneys.
