Medtronic granted FDA approval for PulseSelect AF treatment

Medtronic has received approval from the Food and Drug Administration (FDA) 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 recent European CE mark of the PulseSelect PFA system in November.

Rebecca Seidel, SVP and president of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio, said: “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 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 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.

Dr. Amin Al-Ahmad, clinical cardiac electrophysiologist at St. David's Medical Center in Austin, Texas and one of 67 global operators in the PULSED AF trial, said: "The PulseSelect PFA system ushers the EP community to a new era of safe, effective, and efficient AF ablation that overcomes many challenges in our current practice. 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 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 pre-emptive 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.

Khaldoun Tarakji, MD MPH, chief medical officer of the Cardiac Ablation Solutions business at Medtronic, said: "We are thrilled to see the continuous innovation of our legacy Cryoablation portfolio alongside the approval of the PulseSelect PFA system in the U.S. 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."

Commercialisation of the PulseSelect PFA system will start this year.