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2022 AF Symposium
In Development: Systems for Pulsed Field Ablation (PFA)
At A-Fib.com, we first described Pulsed Field Ablation (Farapulse, Inc.) in the beginning of 2021. See my report: Pulse Field Ablation—Emerging Tech for Atrial Fibrillation. Since then Farapulse, Inc. has been acquired by Boston Scientific.
Today many different companies and different Pulse Field Ablation systems have entered the market. All are still in various stages of investigation, none have been FDA approved.
Current Pulse Field Systems Being Investigated
Dr Moussa Mansour
Dr. Moussa Mansour of Massachusetts General Hospital in Boston, MA presented an overview of these various systems “Technology and Regulatory Status of Current Systems for Pulsed Field Ablation (PFA).” His talk was an important first step for doctors and A-Fib centers trying to incorporate this technology into new practices in the coming years.
Dr. Mansour pointed out that RF energy ablation is defined and limited, whereas Pulsed Field Ablation (PFA) can be varied in many different ways. PFA can be monophasic and biphasic, the duration of the PFA pulses can be varied, the number of pulses can be changed, the breaks between pulses can be varied. PFA can be reversible. The sweet spot is between non-reversible and too much PFA energy which can look like RF.
Leaders Developing Pulsed Field Ablation Systems
I’ll describe the advantages and disadvantages of each system, as they look today. (Only time will tell if my views are accurate.)
Farapulse, Inc. (Boston Scientific). A pioneer and a leader in the field. The Farapulse catheter can be changed to different configurations. In the demos we saw, the Farapulse catheter seemed very easy to use. The basket configuration can be positioned in the opening of a PV similar to how the CryoBalloon is used today, while the petal configuration can be used in flat areas such as the posterior wall.
Biosense Webster multielectrode circular catheter Veripulse designed to work with the Carto EAM system. A leader in the field.
Other Companies Playing Catch-Up
Medtronic PulseSelect Pulsed Field Ablation system uses a multielectrode circular catheter. (To me, this doesn’t seem as effective and efficient as the Farapulse system.) (Jan. 2022: Medtronic announced it will acquire Affera, Inc.)
AFFERA, Inc. single lattice-tip sphere which can switch between Pulsed Field and RF ablation simply by toggling a foot pedal switch. Though the AFFERA, Inc. system is very innovative and seemingly easy to use, the question is will RF really be needed or useful once Pulsed Field ablation becomes standard. Pulsed Field ablation is much faster and easier to do than RF point-by-point ablation. See my 2021 AF Symposium report: Combining Pulsed Field with RF Ablation.
ACUTUS Medical combines their basket catheter non-contact mapping system (AcQ Mapping) with Pulsed Field ablation. See my 2020 AF Symposium report: AcQ 3D Imaging, Mapping and Navigation System. (I confess I’ve no idea how their Dipole Density system works with Pulsed Field Ablation. At first glance, the two systems seem very different.)
Galaxy Medical Centauri Connect box allows EPs to use the same focal RF catheters and mapping systems they now use, but for Pulsed Field Ablation (PFA). Galaxy also has a new Alpha1 ablation catheter for PFA. (Most centers will probably not use their old catheters for PFA ablation.)
Abbott Laboratories also has a circular mapping and ablation catheter they are developing for Pulsed Field Ablation.
Adagio Medical combines ultra-low temperature cryoablation and pulsed field ablation in one catheter. 
It pre-freezes the catheter to the heart tissue, then focuses a pulsed electrical field to the frozen area. See my report from the 2018 AF Symposium: Innovative iCLAS Cyro Catheter by Adagio Medical. I don’t see much of an advantage in freezing a PFA catheter to heart tissue. One of the big advantages of PFA is that contact is not necessary to achieve effective Pulsed Field Ablations.
Also in development is the Kardium Global spherical catheter with 122 gold-plated electrodes on 16 slines which can ablate anywhere in the left atrium and produce continuous lesions. It only requires a 3-second PFA ablation to isolate a PV. It also produces high qualityu 3D activation maps of the left atgrium and can also be used for pacing. It uses GPS 3D navigation and mapping to track the precise location of the Globe catheter inside the atrium.
The Kardium Global system seems to have the potential to challenge current leaders in the PFA field. See Spherical Array Catheter https://a-fib.com/af-2022-symposium-pulsed-field-ablation-integrated-mapping-ablation-spherical-array-catheter-for-a-fib/
Editor’s Comments
It’s Certainly Good News for patients to see so many companies entering the Pulsed Field Ablation field.
Even before FDA approval, the ablation device industry seems to have accepted Pulsed Field Ablation as the future for treating A-Fib. Barring any unforeseen clinical trial complications, Pulsed Field Ablation seems inevitable.
For more about Pulsed Field Ablation, see my 2020 AF Symposium summaries of five abstracts (one-page descriptions of A-Fib research) distributed as a printed digest.
• Lesion Durability and Safety Outcomes of Pulsed Field Ablation
• Pulsed Field Ablation with CTI Lesions Terminates Flutter in a Small Study
• Durability of Pulsed Field Ablation Isolation Over Time: Preliminary Study
• Pulsed Field Ablation vs RF Ablation: A Study in Swine
• Using MRI to Check Pulsed Field Ablations (PFA)
If you find any errors on this page, email us. Y Last updated: Friday, March 18, 2022
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