Skip to content
DraconiticResearch
Search Sources API
197,688 studies31 sourcesUpdated 47 min ago
Peer-reviewedCC BYThe Journal of innovations in cardiac rhythm management

Pulsed Field Ablation for Cardiac Arrhythmias: Industry Landscape and US Food and Drug Administration-approved Platforms (2025).

  • Amar Ghaleb1
  • Abimbola Kolawole1
  • Usher Khan1
  • Arfaat M Khan2
  1. 1Central Michigan University College of Medicine, Mount Pleasant, MI, USA.
  2. 2Division of Cardiology, Henry Ford Health, Detroit, MI, USA.
Read full textPDFDOICite

Abstract

Pulsed field ablation (PFA) has rapidly advanced from an experimental modality to a front-line therapy for catheter ablation of atrial fibrillation (AF). Unlike thermal approaches such as radiofrequency (RF) or cryoablation, PFA relies on irreversible electroporation, producing rapid and selective myocardial lesions with minimal risk of collateral injury. This review examines the contemporary landscape of PFA technology, with emphasis on recent United States Food and Drug Administration (FDA) approvals that have expanded PFA from single-energy, single-shot systems toward focal and hybrid ablation strategies. Particular focus is placed on FDA-approved platforms, including PulseSelect™ (Medtronic, Minneapolis, MN, USA), FARAPULSE™ (Boston Scientific, Marlborough, MA, USA), and VARIPULSE™ (Biosense Webster, Diamond Bar, CA, USA), as well as next-generation systems such as the Affera Sphere-9™ dual-energy RF-PFA platform (Medtronic) and the Volt™ focal PFA system (Abbott, Chicago, IL, USA). Differences in catheter design, energy delivery, workflow, mapping integration, regulatory labeling, and clinical outcomes are reviewed. By contextualizing these platforms within evolving ablation strategies, this review highlights a second evolutionary phase of PFA focused on procedural flexibility, lesion durability, and integration with established electrophysiology (EP) workflows, with implications for future AF management and EP lab practice.

Related

  1. Dual-Energy Pulsed Field and Radiofrequency Ablation With a Contact Force-Sensing Focal Catheter for Ventricular Arrhythmias: Initial Clinical Experience
    A. Darma, S.-E. Waezsada, N. Trajkovska +10
    medRxivPreprintAll rights reservedFull textCardiovascular medicinemedRxiv
  2. India’s DNA synthesis landscape: regulatory frameworks, industry structure, and biosecurity gaps
    Suryesh Kumar Namdeo, Mayra Ameneiros
    Frontiers in bioengineering and biotechnologyPeer-reviewedCC BYFull textEpidemiology & public healthEurope PMCPMCEurope PMC
  3. Adverse Event Landscape of Pulsed Field Ablation Catheters: A Computational Review of FDA MAUDE Post-Market Surveillance Data
    Matthew W. Segar, Kaleb D. Lambeth, Shyon Parsa +1
    Reviews in cardiovascular medicinePeer-reviewedCC BYFull textCardiovascular medicineEurope PMC
  4. Landscape of industry-sponsored oncology trials across the Thai Society of Clinical Oncology (TSCO): a 12-year multicenter analysis.
    Kosin Wirasorn, Jirapath Wiwitkeyoonwong, Jitlada Juengsamarn +17
    BMC cancerPeer-reviewedCC BY-NC-NDFull textPharmacology & toxicologyEurope PMCPMC
  5. Editorial: Management of arrhythmias in acute and intensive care settings
    Martin Balik, Stepan Havranek
    Frontiers in Cardiovascular MedicinePeer-reviewedCC BY 4.0Full textCardiovascular medicineCrossref

Cite

BibTeXRIS
BibTeX
@article{ghaleb2026pulsed,
  title = {{Pulsed Field Ablation for Cardiac Arrhythmias: Industry Landscape and US Food and Drug Administration-approved Platforms (2025).}},
  author = {Amar Ghaleb and Abimbola Kolawole and Usher Khan and Arfaat M Khan},
  journal = {The Journal of innovations in cardiac rhythm management},
  year = {2026},
  month = jul,
  doi = {10.19102/icrm.2026.17073},
  url = {https://europepmc.org/article/MED/42899040},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Pulsed Field Ablation for Cardiac Arrhythmias: Industry Landscape and US Food and Drug Administration-approved Platforms (2025).
AU  - Amar Ghaleb
AU  - Abimbola Kolawole
AU  - Usher Khan
AU  - Arfaat M Khan
PY  - 2026
DA  - 2026/07/15
JO  - The Journal of innovations in cardiac rhythm management
DO  - 10.19102/icrm.2026.17073
UR  - https://europepmc.org/article/MED/42899040
AB  - Pulsed field ablation (PFA) has rapidly advanced from an experimental modality to a front-line therapy for catheter ablation of atrial fibrillation (AF). Unlike thermal approaches such as radiofrequency (RF) or cryoablation, PFA relies on irreversible electroporation, producing rapid and selective myocardial lesions with minimal risk of collateral injury. This review examines the contemporary landscape of PFA technology, with emphasis on recent United States Food and Drug Administration (FDA) approvals that have expanded PFA from single-energy, single-shot systems toward focal and hybrid ablation strategies. Particular focus is placed on FDA-approved platforms, including PulseSelect™ (Medtronic, Minneapolis, MN, USA), FARAPULSE™ (Boston Scientific, Marlborough, MA, USA), and VARIPULSE™ (Biosense Webster, Diamond Bar, CA, USA), as well as next-generation systems such as the Affera Sphere-9™ dual-energy RF-PFA platform (Medtronic) and the Volt™ focal PFA system (Abbott, Chicago, IL, USA). Differences in catheter design, energy delivery, workflow, mapping integration, regulatory labeling, and clinical outcomes are reviewed. By contextualizing these platforms within evolving ablation strategies, this review highlights a second evolutionary phase of PFA focused on procedural flexibility, lesion durability, and integration with established electrophysiology (EP) workflows, with implications for future AF management and EP lab practice.
SN  - 2156-3977
SN  - 2156-3993
ER  -