Electrophysiology covers catheter ablation (radiofrequency, cryo, and pulsed field), 3D mapping systems, and intracardiac echo for treating atrial fibrillation, ventricular tachycardia, and other arrhythmias. Products include mapping systems, ablation catheters using radiofrequency, cryo or pulsed field energy, and implantable rhythm devices. Pulsed field ablation has grown rapidly since its US approvals in 2023 and 2024. Large randomized trials and long-term outcomes data drive physician adoption.

Why it matters

Pulsed field ablation (PFA) - Medtronic Affera, Boston Scientific Farapulse, J&J Varipulse - is reshaping the AF market with tissue-selective, faster procedures. Mapping systems (CARTO, EnSite, Rhythmia) drive catheter pull-through.

Common pitfalls

•A common pitfall is failing to adequately validate software used in 3D mapping systems, which can lead to inaccuracies in cardiac reconstruction and treatment planning.
•Manufacturers sometimes overlook the need for robust cybersecurity controls in networked electrophysiology systems, potentially exposing patient data or device function to unauthorized access.
•Inadequate risk assessment for novel energy sources, such as pulsed field ablation, can result in unforeseen patient harms or device malfunctions.
•A mistake is not performing sufficient usability testing on complex electrophysiology equipment, leading to operator error during critical procedures.

Sources

Heart Rhythm Society · HRS
MedTech Dive · MedTech Dive
AdvaMed - Industry Reports · AdvaMed
Cardiac electrophysiology devices · U.S. Food and Drug Administration (FDA)

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