PFA takes center stage at Heart Rhythm 2025 as medtech companies share new data
Pulsed field ablation (PFA) technologies were the center of attention at Heart Rhythm 2025, the Heart Rhythm Society’s annual meeting in San Diego.
PFA is an ablation technology that involves using high-voltage electrical pulses to treat heart rhythm issues such as paroxysmal and persistent atrial fibrillation (AFib). PFA offerings that have received U.S. Food and Drug Administration (FDA) approval include Medtronic’s PulseSelect and Affera systems, Boston Scientific’s Farapulse system and Johnson & Johnson MedTech’s Varipulse system. A variety of other medtech companies are also working to get ahead in the PFA space as the technique continues to gain more and more momentum.
Thousands of cardiologists, electrophysiologists and cardiac imaging specialists gathered at Heart Rhythm 2025 from April 24-27. A significant number of studies presented over the course of those four days focused on the latest developments in PFA technology.
Two Affera updates from Medtronic
Medtronic, the only healthcare technology company with two FDA-approved PFA systems, was the subject of two separate studies presented during Heart Rhythm 2025.
One analysis examined one-year outcomes among heart patients treated with Medtronic’s Sphere-360 single-shot PFA catheter, a newer part of its Affera product line. The device features a large, conformable lattice design that can be moved into a variety of shapes as necessary.
Researchers found that treatment with Sphere-360 was associated with freedom from arrhythmia recurrence in 88% of patients and chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins. The full study was simultaneously published in Heart Rhythm.[1]
“The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias,” Vivek Reddy, MD, director of cardiac arrhythmia services for the Mount Sinai Health System in New York City, said in a statement. “It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation. The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed.”
The Sphere-360 catheter has not yet gained FDA approval, but Medtronic is preparing to launch a U.S. pivotal trial focused on the device in the months ahead.
The second study presented during Heart Rhythm 2025 was a subanalysis of the Sphere Per-AF Investigational Device Exemption (IDE) trial. It focused on using the Sphere-360 device to create linear lesions in patients who present with persistent AFib. Overall, researchers found that performing linear ablation in conjunction with PVI appeared to be both safe and effective.
Johnson & Johnson MedTech celebrates three separate studies
Johnson & Johnson MedTech used Heart Rhythm 2025 as an opportunity to share early data on its Omnypulse PFA platform, which includes both an Omnypulse PFA catheter and the company’s TruPulse generator. The platform was also designed to integrate with Johnson & Johnson MedTech’s Carto 3 system software.
Johnson & Johnson MedTech's Varipulse PFA catheter. Image courtesy of Johnson & Johnson MedTech.
After three months, treatment with the Omnypulse PFA system was linked to 100% acute PVI with durable isolation in 84.5% of pulmonary veins. In addition, the primary adverse event rate at that three-month endpoint was 3%, and less than 1% of those events were directly related to the catheter. The full study, which is designed to follow patients for at least a year, included nearly 200 patients. It was simultaneously published in JACC: Clinical Electrophysiology.[2]
“The three-month data provide encouraging early evidence of the Omnypulse Platform,” said Mattias Duytschaever MD, PhD, a cardiologist with AZ Sint-Jan Hospital in Belgium, said in a statement. “What’s most compelling is the combination of 100% acute and strong remap success with a low rate of safety events.”
Researchers at Heart Rhythm 2025 also shared new data on Johnson & Johnson MedTech’s Varipulse PFA system and its dual-energy ThermoCool SmartTouch SF Catheter.
The VARIPURE study, for example, included nearly 250 patients treated throughout Europe by operators with a variety of levels of experience. Some of the users were even using the technology for the very first time, Johnson & Johnson MedTech emphasized. Overall, no serious adverse events were reported and no patient complications were associated with using the FDA-approved Varipulse system.
“As adoption of PFA expands, I believe Varipulse can play a key role in broadening access to safe and streamlined ablation procedures,” explained Francis Bessière MD, PhD, a cardiologist with Louis Pradel Hospital in France.
The new ThermoCool study, meanwhile, focused on a new index that suggests lesion depth can help clinicians anticipate when more pulses may be needed during a PFA procedure. A preclinical validation of the index using a swine beating heart model helped illustrate the early promise of this helpful resource.
Updated Farapulse data from Boston Scientific
Heart Rhythm 2025 also featured new data on Boston Scientific’s Farapulse system. Researchers presented new 12-month data on the second phase of its ADVANTAGE AF clinical trial tracking the Farapulse system and the adjunctive use of the Farapoint PFA catheter. Overall, freedom from AFib, atrial flutter and atrial tachycardia was seen in 73.4% of the study’s 255 patients—the trial’s original performance goal was to surpass 40%.
Boston Scientific's Farapulse PFA system. Image courtesy of Boston Scientific.
In addition, the safety event rate was 2.4%, 81% of patients were free from symptomatic documented AFib recurrence and 71.6% of patients had “virtually no atrial arrhythmia burden.” Among patients treated with the Farapoint PFA catheter, meanwhile, 96.4% reported no signs of atrial flutter recurrence.
The full study results were simultaneously published in Circulation.[3] Boston Scientific is presently aiming to secure an expanded approval from the FDA so that Farapulse is cleared to use in patients with persistent AFib. It is now only approved for the treatment of paroxysmal AFib.
“The data collected in this trial continues to support the Farapulse PFA system as a safe and effective therapy, now with evidence highlighting positive results for its use in treating patients who suffer from persistent AFib,” Reddy, the study’s principal investigator, said in a statement.
Abbott’s Volt PFA system linked to key benefits
Researchers also highlighted new data on Abbott’s Volt PFA system, which recently gained CE mark approval. According to Abbott, the proprietary balloon-in-basket design of the Volt’s catheter helps clinicians target tissue with an increased accuracy.
Overall, 12 months after treatment, 83.5% of patients with paroxysmal AFib and 58.1% of patients with persistent AFib remained free from atrial arrhythmia. In addition, the Volt PFA system was linked to consistent improvements in quality-of-life scores and limited adverse safety events, including no reports of hemolysis, coronary artery spasm, pulmonary vein stenosis, acute kidney injury or phrenic nerve injury. All data came from the Volt CE Mark Study.
The full analysis was published in Heart Rhythm.[4]
“Our goal from the beginning with the Volt PFA System was to design a PFA system that would provide outstanding results in patients battling a range of atrial arrhythmias, and the latest data from the Volt CE Mark Study is confirmation that the system will truly impact patient care in a positive way,” Christopher Piorkowski, MD, chief medical officer of Abbott's electrophysiology business, said in a statement.
The Volt PFA System has not yet gained FDA approval.
Additional companies share PFA updates at Heart Rhythm 2025
Additional data were also presented during the big conference in San Diego. Kardium, a Canadian medtech company, shared one-year results from its PULSAR IDE study. The company’s Globe Pulsed Field System—which combines single-shot PVI, advanced mapping and atrial ablation into a single catheter—was linked to freedom from paroxysmal AFib in more than 78% of patients, a primary safety event rate of just 0.6% and a device-related primary safety event rate of 0%.
“This study is another big step towards achieving our mission at Kardium of delivering the best treatment for atrial fibrillation,” Kevin Chaplin, the company’s CEO, said in a statement.
Field Medical's FieldForce Ablation System. Image courtesy of Field Medical.
California-based Field Medical, meanwhile, presented first-in-human data on its FieldForce Ablation System, which features a high-voltage focal PFA catheter designed to deliver pulses in a fraction of a second and treat a variety of cardiac arrhythmias. Though relatively new compared to some other PFA technologies, FieldForce was featured in a total of eight different presentations at Heart Rhythm 2025. One of those presentations included new data on the technology’s impact on patients with scar-related ventricular tachycardia. According to that study, treatment with the FieldForce system resulted in a freedom from ventricular tachycardia rate of 78%.
Steven Mickelsen, MD, CEO and founder of Field Medical, is already a veteran of the PFA space. He previously founded Farapulse, which Boston Scientific later acquired.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.