Sam Brusco, Associate Editor01.31.24
Pulsed-field ablation (PFA) is a new, promising ablation modality to treat atrial fibrillation (AFib). It’s an adaptation of direct current ablation—the first energy source used for catheter ablation—used in the 1980s to treat cardiac arrhythmias. That ablative method was replaced by radiofrequency (RF) energy because it’s more efficient and precise.
PFA applies more controlled high-intensity pulses over a very short time, and represents the field’s next major advance. It’s a more tissue-specific form of energy delivery than thermal—during PFA, adjacent myocardial cell membranes are destabilized, which results in nanoscale pores, increased cell membrane permeability, and leakage of cell contents. This results in “selective ablation”—either immediate necrosis or delayed, orchestrated cell collapse.
The goal of PFA is to achieve pulmonary vein isolation (PVI), the standard of care for interventional treatment of AFib. Recently, PFA technology has been of great interest to major medical device makers because the technology has the potential to become the main energy source for PVI and beyond.
“Launching the first FDA-approved PFA technology is not just a milestone; the PulseSelect PFA system is setting a new standard in safety for AF ablation with excellent efficacy and efficiency. It’s a major step towards fulfilling our vision of providing disruptive electrophysiology solutions for patients,” said Rebecca Seidel, SVP and president of Medtronic’s Cardiac Ablation Solutions business. “The PulseSelect PFA system, together with the CE marked Affera mapping and ablation system and our strong Cryo platform, enables us to provide a broad portfolio of solutions to clinicians and their patients, all developed with years of research and supported by compelling scientific evidence.”
The ”plug-and-play” system can be used with any mapping system or only fluoroscopy, Medtronic boasted. It also has built-in safety features of a phrenic nerve test pulse, a non-therapeutic, low-voltage pulse that preemptively assesses catheter proximity to the phrenic nerve before delivering a therapeutic application. PulseSelect grabbed CE mark approval in November.
“With nearly 40,000 patients treated to date in clinical and commercial settings, the Farapulse PFA System continues to demonstrate a promising safety and effectiveness profile, upon which this study seeks to build,” said Dr. Brad Sutton, chief medical officer, AF Solutions, Boston Scientific. “The AVANT GUARD trial is exciting in that it has the potential to change clinical practice by advancing the therapy to be utilized as an earlier treatment for persistent AF, which may lead to better long-term outcomes and establish the Farapulse PFA System as the preferred method for treating the disease.”
At the end of January, Boston Scientific announced it had received FDA approval for the Farapulse PFA system.
“At Biosense Webster, we are working to deliver a differentiated PFA portfolio integrated with 3D cardiac mapping to address the real-world, unmet needs of electrophysiologists and the patients they treat,” said Biosense Webster president Jasmina Brooks.
Volt PFA takes a different approach, pairing a balloon-in-basket catheter with the company’s EnSite X EP heart mapping system to visualize and position the Volt PFA catheter in the heart. Abbott said the balloon feature offers more efficient energy transfer to tissue, improving how the catheter creates lesions to stop erratic heart signals.
“Daily life for the millions of people with AFib can be difficult as symptoms often include palpitations, shortness of breath, dizziness and chest pain, making it critical that physicians treat the issue as soon as possible,” said Christopher Piorkowski, M.D., chief medical officer of Abbott’s electrophysiology business. “With AFib cases expected to rise continuously, Abbott’s Volt PFA System meets a growing demand for a more innovative solution that reduces the patient procedure time and overall hospital stay, getting them back to living a fuller, longer life.”
PFA applies more controlled high-intensity pulses over a very short time, and represents the field’s next major advance. It’s a more tissue-specific form of energy delivery than thermal—during PFA, adjacent myocardial cell membranes are destabilized, which results in nanoscale pores, increased cell membrane permeability, and leakage of cell contents. This results in “selective ablation”—either immediate necrosis or delayed, orchestrated cell collapse.
The goal of PFA is to achieve pulmonary vein isolation (PVI), the standard of care for interventional treatment of AFib. Recently, PFA technology has been of great interest to major medical device makers because the technology has the potential to become the main energy source for PVI and beyond.
1. Medtronic
Medtronic won the race to bring PFA to the U.S. market with U.S. Food and Drug Administration (FDA) approval of its PulseSelect PFA system. PulseSelect can treat both paroxysmal (sudden and intermittent) and persistent AFib. The approval was supported by the company’s PULSED AF study, which showed 0.7% safety event rate and clinical success rates of 80% for both types of AFib.“Launching the first FDA-approved PFA technology is not just a milestone; the PulseSelect PFA system is setting a new standard in safety for AF ablation with excellent efficacy and efficiency. It’s a major step towards fulfilling our vision of providing disruptive electrophysiology solutions for patients,” said Rebecca Seidel, SVP and president of Medtronic’s Cardiac Ablation Solutions business. “The PulseSelect PFA system, together with the CE marked Affera mapping and ablation system and our strong Cryo platform, enables us to provide a broad portfolio of solutions to clinicians and their patients, all developed with years of research and supported by compelling scientific evidence.”
The ”plug-and-play” system can be used with any mapping system or only fluoroscopy, Medtronic boasted. It also has built-in safety features of a phrenic nerve test pulse, a non-therapeutic, low-voltage pulse that preemptively assesses catheter proximity to the phrenic nerve before delivering a therapeutic application. PulseSelect grabbed CE mark approval in November.
2. Boston Scientific
Boston Scientific entered the PFA race in early January by beginning its 500-patient AVANT GUARD trial to evaluate the Farapulse PFA for persistent AFib. The company’s claim to fame in this trial is that AVANT GUARD is the first to evaluate PFA as a frontline therapy for persistent AFib. The company also said it expects FDA approval for Farapulse in Q1 2024.“With nearly 40,000 patients treated to date in clinical and commercial settings, the Farapulse PFA System continues to demonstrate a promising safety and effectiveness profile, upon which this study seeks to build,” said Dr. Brad Sutton, chief medical officer, AF Solutions, Boston Scientific. “The AVANT GUARD trial is exciting in that it has the potential to change clinical practice by advancing the therapy to be utilized as an earlier treatment for persistent AF, which may lead to better long-term outcomes and establish the Farapulse PFA System as the preferred method for treating the disease.”
At the end of January, Boston Scientific announced it had received FDA approval for the Farapulse PFA system.
3. Johnson & Johnson
Johnson & Johnson MedTech’s Biosense Webster captured the first Japanese PFA approval about a week later, with Varipulse to treat symptomatic drug refractory recurrent paroxysmal AFib. The platform also leverages Biosense Webster’s Carto 3, a 3D cardiac mapping system. Varipulse is currently pending CE mark in the EU.“At Biosense Webster, we are working to deliver a differentiated PFA portfolio integrated with 3D cardiac mapping to address the real-world, unmet needs of electrophysiologists and the patients they treat,” said Biosense Webster president Jasmina Brooks.
4. Abbott
Abbott Laboratories was the next to join the party with its mid-January announcement of the first procedures completed using its Volt PFA system. More than 30 patients were treated in Australia as part of the company’s Volt CE mark study, with upcoming procedures in Asia Pacific and Europe.Volt PFA takes a different approach, pairing a balloon-in-basket catheter with the company’s EnSite X EP heart mapping system to visualize and position the Volt PFA catheter in the heart. Abbott said the balloon feature offers more efficient energy transfer to tissue, improving how the catheter creates lesions to stop erratic heart signals.
“Daily life for the millions of people with AFib can be difficult as symptoms often include palpitations, shortness of breath, dizziness and chest pain, making it critical that physicians treat the issue as soon as possible,” said Christopher Piorkowski, M.D., chief medical officer of Abbott’s electrophysiology business. “With AFib cases expected to rise continuously, Abbott’s Volt PFA System meets a growing demand for a more innovative solution that reduces the patient procedure time and overall hospital stay, getting them back to living a fuller, longer life.”