FDA Approves Medtronic's Novel PulseSelect™ for Atrial Fibrillation Treatment

Medtronic plc has recently announced that its PulseSelect Pulsed Field Ablation (PFA) System has received approval from the United States Food and Drug Administration (FDA) for the treatment of both paroxysmal and persistent atrial fibrillation (AF). This approval marks a significant milestone, as the PulseSelect PFA System is touted for setting a new standard in safety for AF ablation, boasting notable efficacy and efficiency.

The PulseSelect PFA System incorporates distinctive safety features, including a phrenic nerve test pulse. This non-therapeutic low voltage pulse allows for an upfront assessment of catheter proximity to the phrenic nerve before administering a therapeutic application.

Designed for rapid and effective pulmonary vein isolation (PVI), the system ensures consistent and predictable energy delivery alongside catheter maneuverability. The PULSED AF study reinforces the system's safety, revealing a 0.7% safety event rate and clinical success rates of 80% for both paroxysmal and persistent AF patients.

In terms of versatility, the PulseSelect PFA System is described as a plug-and-play system compatible with any mapping system or fluoroscopy alone. The nine-electrode catheter features fixed spacing, providing a reliable and consistent electric field for contiguous ablation. The catheter design emphasizes maneuverability and access to various anatomical structures, boasting compatibility with a 10Fr sheath, including the custom bidirectional FlexCath Contour™ sheath.

Additionally, the PulseSelect PFA System holds the distinction of being the first FDA Breakthrough-designated PFA technology to receive approval. This designation aims to expedite patient access to medical devices with the potential to significantly impact the diagnosis or treatment of life-threatening conditions. In summary, Medtronic's PulseSelect PFA System, now FDA-approved, emerges as an innovative and safe solution for treating atrial fibrillation, offering advanced features and benefits in the field of AF ablation technology.


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