Medtronic has announced that the US Food and Drug Administration (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 CE mark of the 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,” said Rebecca Seidel, SVP and president of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. “It’s a major step towards fulfilling our vision of providing disruptive electrophysiology solutions for patients.
“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 company says in a press release. The PulseSelect PFA system’s safety, efficacy, and efficiency is underscored by data from 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 [electrophysiology] community to a new era of safe, effective, and efficient AF ablation that overcomes many challenges in our current practice,” said Amin Al-Ahmad (St David’s Medical Center, Austin, USA), 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 is designed as a plug-and-play system, and can be used with any mapping system or with fluoroscopy. Safety features include a phrenic nerve test pulse, a non-therapeutic low voltage pulse that provides a pre-emptive assessment of catheter proximity to the phrenic nerve prior to delivering a therapeutic application.
Additionally, the device features fixed spacing for the nine-electrode catheter, which is designed to produce 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 9Fr bidirectional catheter is intended to enhance manoeuvrability and access to various anatomical structures and is compatible with a 10Fr sheath, including the custom bidirectional FlexCath Contour sheath.
“We are thrilled to see the continuous innovation of our legacy Cryoablation portfolio alongside the approval of the PulseSelect PFA system in the USA,” said Khaldoun Tarakji, chief medical officer of the Cardiac Ablation Solutions business at Medtronic. “Every patient deserves the best care. What motivates all of us at Medtronic is the privilege of serving patients by empowering electrophysiologists globally with the safest and most effective ablation technologies that seamlessly integrate with their workflows and enable them to tailor therapy based on their patients’ needs.”
The PulseSelect PFA system is also the first FDA Breakthrough-designated PFA technology to be approved. Medtronic is to begin commercialisation of the system in early 2024.
