About PFA therapy

Non-thermal mechanism of action for cardiac ablation

Unlike thermal cardiac ablation methods, pulsed field ablation (PFA) therapy uses short bursts of electrical pulses to treat atrial fibrillation (AFib). The goal of PFA therapy is to isolate and target specific characteristics of cardiac tissue for irreversible electroporation (IRE), inducing cell death and durable lesions using a non-thermal energy source.

How PFA therapy works
Design and workflow

PFA preferentially electroporates cardiomyocytes¹

PFA preferentially ablates cardiac cells due to the lower damage threshold for cardiomyocytes, minimizing the risk of collateral injury to adjacent structures. While cardiomyocytes are more susceptible to PFA, other tissue and cell types are more resistant and can remain uninjured despite exposure to the field.

Irreversible electroporation²

Unlike thermal ablation that causes cell death by local tissue temperature change, PFA applies ultra-rapid electrical pulses above a tissue cell’s specific electrical threshold, destabilizing the cell membrane and forming nanoscale pores, resulting in cell death.

Reversible electroporation can occur if pores are not large or durable enough to cause permanent cell death, but could show immediate loss of intracardiac electrograms. This could be perceived as acute isolation through cardiac stunning without achieving the irreversible electroporation needed for durable lesions.

Optimized catheter design for pulmonary vein isolation (PVI)

The 5-spline FARAWAVE™ Pulsed Field Ablation Catheter is the optimal shape to achieve catheter placement in a range of pulmonary vein (PV) anatomies and address PFA energy delivery needs. No other design test demonstrated the same maneuverability, variable distal shape tips or circumference ablation capabilities, all without the need to manually manage electrode activation.

Biophysics Part 1: Learn about the tissue-selectivity of PFA and the development of the FARAWAVE PFA Catheter, emphasizing the iterative design process and preclinical evaluations.

Biophysics Part 2: Explore the comparative advantages of the FARAWAVE PFA Catheter, highlighting ease of use, safety benefits, reduced procedural risks and improved patient outcomes.

Design evolution chart of the FARAWAVE pulsed field aplation catheter over 10 years.

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Prioritizing efficacy while minimizing unwanted artifacts

Optimizing PFA delivery involves numerous elements of catheter and waveform design in order to create a field of effect for irreversible electroporation (IRE) without causing unwanted artifacts. The extensive FARAWAVE PFA Catheter development timeline in both the pre-clinical and clinical stages drove to balance these factors into the waveform that has now been used in so many patients across the globe.

Proven 8-application workflow

The FARAPULSE dosing protocol is simple yet effective in delivering durable lesions across the PV antrum and ostium. Each vein is preferentially ablated via eight 2.5-second applications utilizing both distal shapes in a prescribed series.

FARAPULSE catheter, waveform and dosing optimizations

Brendan Koop, PhD, details the biophysics and development needs for electroporation optimized for the ablation of cardiomyocytes. This overview explains the development of a catheter for simplified positioning, the waveform for reduced potential of unwanted artifact, and therapeutic dosing for optimized and confident effect.

CONTINUE LEARNING

PFA training

Discover training sessions and interactive learning on the EDUCARE training platform to enhance your knowledge of FARAPULSE and PFA therapy.

Explore PFA training

EXAMINE THE EVIDENCE

PFA clinical data

With more published clinical evidence than any other PFA system, FARAPULSE is dedicated to transforming the treatment of AFib.

Discover PFA clinical data

FARAPULSE™ Pulsed Field Ablation System indications, safety and warnings

References:
1. Reddy VY, Neuzil P, Koruth JS, et al. Pulsed field ablation for pulmonary vein isolation in atrial fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-26.
2. Kotnik T, Kramar P, Pucihar G, et al. Cell membrane electroporation-Part 1: The phenomenon. IEEE Electrical Insulation. 2012;28(5):14-23.

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