Medical Design Briefs - November 2024 - 37

Unlike traditional continuous-wave
ablation methods, PFA induces irreversible
electroporation, leading to cell
death and tissue necrosis while preserving
the extracellular matrix and adjacent
structures. This unique mechanism of
action makes PFA particularly well-suited
for cardiac ablation procedures, where
precise lesion formation and tissue preservation
are critical.
Applications in Cardiac Ablation.
PFA holds great promise for the treatment
of cardiac arrhythmias, including
atrial fibrillation (AF). By selectively
targeting myocardial tissue while sparing
the surrounding structures, PFA
can create durable lesions necessary
for restoring normal electrical conduction
pathways in the heart. Clinical
studies have demonstrated the safety
and efficacy of PFA in achieving pulmonary
vein isolation, the cornerstone
of AF ablation therapy.
* In December 2023, Medtronic announced
that the United States Food
and Drug Administration (FDA) approved
its PulseSelect™ Pulsed Field
Ablation (PFA) System for the treatment
of both paroxysmal and persistent
AF. This is the first PFA technology
to receive FDA approval and
closely follows the recent European
CE (Conformité Européenne) Mark
for the PulseSelect PFA system in November
2023.
* In January 2024, Boston Scientific received
FDA approval for the FARAPULSE™
Pulsed Field Ablation (PFA)
System.
* J&J Biosense Webster announced it will
begin commercialization in Japan of the
VARIPULSE® Platform and the TRUPULSE
multichannel PFA generator.
* Pulse Biosciences filed an FDA 510(k)
application for its CellFX® Nanosecond
Pulsed Field Ablation™ (nsPFA)
technology for the treatment of AF.
Advantages over Traditional Ablation
Techniques. PFA offers several advantages
compared to conventional RF
or cryoablation. Advantaged of PFA
include shorter procedure times, reduced
risk of collateral damage, and
enhanced lesion transmurality. Additionally,
PFA can be performed without
the need for extensive tissue contact
or cooling, making it particularly
suitable for use in challenging anatomical
locations or patients with
structural heart disease.
Medical Design Briefs, November 2024
Crest-to-Crest® Wave Springs
Evolving Technologies. As research in
PFA continues to advance, new technologies
and delivery systems are being developed
to further optimize procedural outcomes
and expand clinical applications.
These include advanced catheter designs,
real-time imaging modalities and computational
modeling techniques aimed at improving
lesion predictability and efficacy.
Future Directions and Challenges
While the potential of pulsed field ablation
in electrosurgery is promising, several
challenges and opportunities lie
ahead. Further clinical studies are needed
to establish long-term safety and efficacy
outcomes, particularly in comparison
to established ablation techniques.
Standardization of procedural protocols
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Medical Design Briefs - November 2024

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